Effect of Chronic ACE and DPP4 Inhibition on Blood Pressure | NCT02130687 | Trialant
NCT02130687
Sponsor
Vanderbilt University
Status
Completed
Last Update Posted
Mar 2, 2022Actual
Enrollment
106Actual
Phase
Not Applicable
Conditions
Type 2 Diabetes Mellitus
Hypertension
Interventions
Placebo
Sitagliptin
Aprepitant
Mixed Meal Test (MMT)
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02130687
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
121253
Secondary IDs
Not provided
Brief Title
Effect of Chronic ACE and DPP4 Inhibition on Blood Pressure
Official Title
Contribution of Substance P to Blood Pressure Regulation in the Setting of Dipeptidyl Peptidase IV (DPP4) and Angiotensin-Converting Enzyme (ACE) Inhibition
Acronym
Not provided
Organization
Vanderbilt University Medical CenterOTHER
Status Module
Record Verification Date
Feb 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2014
Primary Completion Date
May 2020Actual
Completion Date
Aug 2020Actual
First Submitted Date
Apr 30, 2014
First Submission Date that Met QC Criteria
May 2, 2014
First Posted Date
May 5, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 17, 2021
Results First Submitted that Met QC Criteria
Jul 1, 2021
Results First Posted Date
Jul 26, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 8, 2022
Last Update Posted Date
Mar 2, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Nancy J. Brown, MD, Hugh Jackson Morgan Professor, Vanderbilt UniversityPrincipal Investigator
Lead Sponsor
Vanderbilt UniversityOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
In this study the investigators will test the hypothesis that dipeptidyl peptidase IV (DPP4) inhibition attenuates the antihypertensive effect of angiotensin-converting enzyme (ACE) inhibition but not angiotensin receptor blockade or calcium channel blockade. The investigators further hypothesize that this effect is mediated by substance P.
Detailed Description
The use of dipeptidyl peptidase IV (DPP4) inhibitors for the treatment of type 2 diabetes (T2DM) is growing rapidly. The majority of patients with T2DM are also taking ACE inhibitors or angiotensin receptor blockers (ARBs) in order to reduce cardiovascular and renal morbidity and mortality. DPP4 and ACE inhibitors share the common vasoactive substrate substance P. Substance P acts as a vasodilator but also activates the sympathetic nervous system. Understanding the interactive effects of DPP4 and ACE inhibitors on blood pressure and neurohumoral activation has important implications for the millions of patients with T2DM who take these drugs concurrently.
Conditions Module
Conditions
Type 2 Diabetes Mellitus
Hypertension
Keywords
Type 2 Diabetes Mellitus
Hypertension
Angiotensin Converting Enzyme Inhibitors
Dipeptidyl Peptidase IV Inhibitors
Sitagliptin
Aprepitant
Ramipril
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
106Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Amlodipine
Active Comparator
Subjects in this arm will receive calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Drug: Placebo
Drug: Sitagliptin
Drug: Aprepitant
Other: Mixed Meal Test (MMT)
Ramipril
Experimental
Subjects will receive ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Drug: Placebo
Drug: Sitagliptin
Drug: Aprepitant
Other: Mixed Meal Test (MMT)
Valsartan
Active Comparator
Subjects will receive ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Drug: Placebo
Drug: Sitagliptin
Drug: Aprepitant
Other: Mixed Meal Test (MMT)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Subjects will receive two capsules of placebo to preserve the blinding of the study.
In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Arterial Blood Pressure
The primary analyses will focus on mean arterial blood pressure, heart rate, and norepinephrine (NE) concentrations during ramipril versus ramipril+sitagliptin, and during ramipril+sitagliptin versus ramipril+sitagliptin+aprepitant. We will make similar comparisons within the valsartan- and placebo-treated groups. In addition, we will compare blood pressure and heart rate parameters among the ramipril-treated, valsartan-treated, and placebo-treated groups during comparable concurrent treatment.
4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)
Heart Rate
The primary analyses will focus on blood pressure, heart rate, and norepinephrine (NE) concentrations during ramipril versus ramipril+sitagliptin, and during ramipril+sitagliptin versus ramipril+sitagliptin+aprepitant. We will make similar comparisons within the valsartan- and placebo-treated groups. In addition, we will compare blood pressure and heart rate parameters among the ramipril-treated, valsartan-treated, and placebo-treated groups during comparable concurrent treatment.
4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)
Norepinephrine (NE) Concentrations
The primary analyses will focus on blood pressure, heart rate, and norepinephrine (NE) concentrations during ramipril versus ramipril+sitagliptin, and during ramipril+sitagliptin versus ramipril+sitagliptin+aprepitant. We will make similar comparisons within the valsartan- and placebo-treated groups. In addition, we will compare blood pressure and heart rate parameters among the ramipril-treated, valsartan-treated, and placebo-treated groups during comparable concurrent treatment.
4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)
Secondary Outcomes
Measure
Description
Time Frame
Low Frequency Variability of Blood Pressure Activity
Low frequency variability of systolic blood pressure will be measured using spectral analysis.
for 5 minutes on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)
Glucose
Other Outcomes
Measure
Description
Time Frame
Aldosterone, Angiotensin II, and Plasma Renin Activity (PRA)
renin-angiotensin system measurements were not done because there were not significant differences in blood pressure
for 4.5 hours on the 7th day of each intervention
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Age 18 to 80 years old
For female subjects the following conditions must be met:
Postmenopausal status for at least 1 year, or Status-post surgical sterilization, or If of childbearing potential, utilization of barrier methods of birth control and willingness to undergo urine β-HCG testing prior to drug treatment and on every study day
T2DM, as defined by 1 or more of the following at the time of screening visit:
Hgb A1C ≥6.5%, or
Fasting plasma glucose ≥126mg/dL, or
2-hour plasma glucose ≥200 mg/dL following 75gr oral glucose load
Hypertension, as defined by:
Seated SBP ≥130 mm Hg on three occasions documented in medical record, or
Seated DBP ≥80 mm Hg on three occasions documented in medical record, or
Treatment with antihypertensive medications for a minimum of 6 months
Exclusion Criteria:
Type 1 diabetes
Poorly controlled T2DM, defined as Hgb A1C>8.7%
Use of anti-diabetic medications other than metformin for at least 12 months prior to initiation of the study
Secondary hypertension
Subjects who have participated in a weight-reduction program during the last 6 months and whose weight has increased or decreased more than 5 kg over the preceding 6 months
Pregnancy
Breast-feeding
Treatment with drugs primarily metabolized through CYP3A4 (e.g. cisapride, pimozide)
Clinically significant gastrointestinal impairment that could interfere with drug absorption
Cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy and diastolic dysfunction acceptable), deep vein thrombosis, pulmonary embolism, second- or third-degree AV block, mitral valve stenosis, or hypertrophic cardiomyopathy
Impaired hepatic function (aspartate amino transaminase [AST] and/or alanine amino transaminase [ALT] >3 x upper limit of normal range)
Impaired renal function (eGFR< 50mL/min/1.73m2 as determined by the MDRD equation)
History or presence of immunological or hematological disorders.
History of pancreatitis or know pancreatic lesion
History of angioedema while taking an ACE inhibitor
Hematocrit <35%
Treatment with anticoagulants
Diagnosis of asthma requiring use of inhaled β-2 agonist more than 1 time per week
Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
Treatment with systemic glucocorticoids within the last 6 months
Treatment with lithium salts
Treatment with any investigational drug in the 1 month preceding the study
Mental conditions rendering the subject unable to understand the nature, scope, or possible consequences of the study
Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Mashayekhi M, Wilson JR, Jafarian-Kerman S, Nian H, Yu C, Shuey MM, Luther JM, Brown NJ. Association of a glucagon-like peptide-1 receptor gene variant with glucose response to a mixed meal. Diabetes Obes Metab. 2021 Jan;23(1):281-286. doi: 10.1111/dom.14216. Epub 2020 Oct 22.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Participants were enrolled if they met inclusion and exclusion criteria. 174 were consented to enroll 106. In other words, 68 of 174 consented were excluded because they did not meet inclusion/exclusion criteria.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Amlodipine
Subjects in this arm will receive calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.
In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.
Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.
Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.
Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.
FG001
Ramipril
Subjects will receive ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.
In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.
Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.
Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.
Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.
FG002
Valsartan
Subjects will receive ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.
In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.
Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.
Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.
Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.
Periods
Title
Milestones
Reasons Not Completed
Washout
Type
Comment
Milestone Data
STARTED
FG00036 subjects
FG00135 subjects
FG00235 subjects
COMPLETED
FG00036 subjects
FG00133 subjects
FG00231 subjects
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0024 subjects
Drug 1 Only
Type
Comment
Milestone Data
STARTED
FG00036 subjects
FG00133 subjects
FG00231 subjects
COMPLETED
FG000
Crossover Period 1
Type
Comment
Milestone Data
STARTED
FG00033 subjects
FG00130 subjects
FG00230 subjects
COMPLETED
FG000
Drug 1 Only Between Periods 1 and 2
Type
Comment
Milestone Data
STARTED
FG00033 subjects
FG00130 subjects
FG00230 subjects
COMPLETED
FG000
Crossover Period 2
Type
Comment
Milestone Data
STARTED
FG00033 subjects
FG00126 subjects
FG00229 subjects
COMPLETED
FG000
Drug 1 Only Between Periods 2 and 3
Type
Comment
Milestone Data
STARTED
FG00033 subjects
FG00126 subjects
FG00229 subjects
COMPLETED
FG000
Crossover Period 3
Type
Comment
Milestone Data
STARTED
FG00033 subjects
FG00125 subjects
FG00227 subjects
COMPLETED
FG000
Baseline Characteristics Module
Baseline Analysis Population Description
Baseline characteristics are provided for all participants who were randomized whether or not they received study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Amlodipine
Subjects in this arm will receive calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.
In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.
Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.
Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.
Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Mean Arterial Blood Pressure
The primary analyses will focus on mean arterial blood pressure, heart rate, and norepinephrine (NE) concentrations during ramipril versus ramipril+sitagliptin, and during ramipril+sitagliptin versus ramipril+sitagliptin+aprepitant. We will make similar comparisons within the valsartan- and placebo-treated groups. In addition, we will compare blood pressure and heart rate parameters among the ramipril-treated, valsartan-treated, and placebo-treated groups during comparable concurrent treatment.
Posted
Mean
Standard Deviation
mmHg
4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)
ID
Title
Description
OG000
Amlodipine Plus Placebo/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
Adverse Events Module
Frequency Threshold
5
Time Frame
Adverse event data were collected through study completion or for approximately 15 weeks.
Description
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Washout Prior to Amlodipine
Subjects in this arm received calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. Subjects underwent washout prior to starting amlodipine.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
atrial fibrillation
Cardiac disorders
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
cough
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Nancy J. Brown, M.D.
Yale University
16153644022
nancy.j.brown@yale.edu
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP_ICF
Yes
Yes
Yes
Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.
Amlodipine
Ramipril
Valsartan
Januvia
Aprepitant
Drug
Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.
Amlodipine
Ramipril
Valsartan
Emend
Mixed Meal Test (MMT)
Other
The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.
Amlodipine
Ramipril
Valsartan
measure of effectiveness of DPP4 inhibitor
fasting at 3 hours on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)
Insulin
Measure of insulin resistance.
fasting insulin measured at 3 hours on the 7th day of each intervention (placebo, sitagliptin, sitatliptin+aprepitant)
Dipeptidyl Peptidase IV (DPP4) Activity
Measure of DPP4 inhibitor administration.
for 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)
Angiotensin Converting Enzyme (ACE) Activity
This is a measure of activity of the angiotensin-converting enzyme (ACE). The assay is a kinetic assay (Labcore) that measures the rate of cleavage of an added ACE substrate over time and the results are reported in Units, which represent the rate of increase in fluorescent metabolite over 30 minutes under standard conditions at 37C.
for 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)
Mean Arterial Blood Pressure
Average of measurements made every five minutes beginning just prior to (time 0) and for four hours after the ingestion of a mixed meal
Value provided is the AVERAGE of measurements made every five minutes prior to (time 0) and for four four hours after ingestion of a mixed meal.
Heart Rate
The average of measurements made every five minutes prior to (time 0) and for four four hours after ingestion of a mixed meal
Value provided is the average of measurements made every five minutes prior to (time 0) and for four four hours after ingestion of a mixed meal.
Neuropeptide Y
Measurement of Neuropeptide Y (NPY) concentrations
Neuropeptide Y concentration prior to ingestion of the mixed meal.
24hr Urinary Testing for Sodium
Subjects will collect 24hr urine sample and bring with to the study day for analysis
Urine was collected for sodium for 24 hrs prior to each of the study days listed below. Study days occurred after each 7-day treatment arm (placebo/placebo, sitagliptin/placebo, or sitagliptin/aprepitant) within 3 anti-hypertensive groups.
33 subjects
FG00130 subjects
FG00230 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0021 subjects
33 subjects
FG00130 subjects
FG00230 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
33 subjects
FG00126 subjects
FG00229 subjects
NOT COMPLETED
FG0000 subjects
FG0014 subjects
FG0021 subjects
33 subjects
FG00126 subjects
FG00229 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
33 subjects
FG00125 subjects
FG00227 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0022 subjects
33 subjects
FG00125 subjects
FG00227 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
BG001
Ramipril
Subjects will receive ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.
In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.
Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.
Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.
Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.
BG002
Valsartan
Subjects will receive ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.
In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.
Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.
Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.
Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.
BG003
Total
Total of all reporting groups
36
BG00135
BG00235
BG003106
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00058.1± 10.9
BG00152.9± 9.9
BG00257.9± 10.4
BG00356.3± 10.6
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00018
BG00118
BG00217
BG00353
Male
BG00018
BG00117
BG00218
BG00353
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
Asian
BG0001
BG0011
BG0020
BG0032
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
Black or African American
BG00011
BG0016
BG0029
BG00326
White
BG00024
BG00127
BG00225
BG00376
More than one race
BG0000
BG0011
BG0021
BG0032
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00036
BG00135
BG00235
BG003106
OG001
Amlodipine Plus Sitagliptin/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG002
Amlodipine Plus Sitagliptin/Aprepitant
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG003
Ramipril Plus Placebo/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
OG004
Ramipril Plus Sitagliptin/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
OG005
Ramipril Plus Sitagliptin/Aprepitant
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG006
Valsartan Plus Placebo/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG007
Valsartan Plus Sitagliptin/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG008
Valsartan Plus Sitagliptin/Aprepitant
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
Units
Counts
Participants
OG00033
OG00133
OG00233
OG00327
OG00425
OG00528
OG00628
OG00729
OG00829
Title
Denominators
Categories
Title
Measurements
OG00094.42± 7.53
OG00193.41± 8.75
OG00291.54± 7.80
OG00390.21± 12.46
OG00489.88± 9.67
OG00586.95± 10.16
OG00694.54± 9.96
OG00793.71± 10.75
OG00893.98± 10.75
Primary
Heart Rate
The primary analyses will focus on blood pressure, heart rate, and norepinephrine (NE) concentrations during ramipril versus ramipril+sitagliptin, and during ramipril+sitagliptin versus ramipril+sitagliptin+aprepitant. We will make similar comparisons within the valsartan- and placebo-treated groups. In addition, we will compare blood pressure and heart rate parameters among the ramipril-treated, valsartan-treated, and placebo-treated groups during comparable concurrent treatment.
Posted
Mean
Standard Deviation
beats per minute
4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)
ID
Title
Description
OG000
Amlodipine Plus Placebo/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG001
Amlodipine Plus Sitagliptin/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG002
Amlodipine Plus Sitagliptin/Aprepitant
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG003
Ramipril Plus Placebo/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
OG004
Ramipril Plus Sitagliptin/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
OG005
Ramipril Plus Sitagliptin/Aprepitant
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG006
Valsartan Plus Placebo/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG007
Valsartan Plus Sitagliptin/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG008
Valsartan Plus Sitagliptin/Aprepitant
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
Units
Counts
Participants
OG00033
OG00133
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG00069.59± 9.75
OG00170.43± 9.79
OG00269.41± 9.84
OG003
Primary
Norepinephrine (NE) Concentrations
The primary analyses will focus on blood pressure, heart rate, and norepinephrine (NE) concentrations during ramipril versus ramipril+sitagliptin, and during ramipril+sitagliptin versus ramipril+sitagliptin+aprepitant. We will make similar comparisons within the valsartan- and placebo-treated groups. In addition, we will compare blood pressure and heart rate parameters among the ramipril-treated, valsartan-treated, and placebo-treated groups during comparable concurrent treatment.
Posted
Mean
Standard Deviation
pg/mL
4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)
ID
Title
Description
OG000
Amlodipine Plus Placebo/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG001
Amlodipine Plus Sitagliptin/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG002
Amlodipine Plus Sitagliptin/Aprepitant
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG003
Ramipril Plus Placebo/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
OG004
Ramipril Plus Sitagliptin/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
OG005
Ramipril Plus Sitagliptin/Aprepitant
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG006
Valsartan Plus Placebo/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG007
Valsartan Plus Sitagliptin/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG008
Valsartan Plus Sitagliptin/Aprepitant
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
Units
Counts
Participants
OG00032
OG00132
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG000741.65± 660.82
OG001730.88± 613.69
OG002610.65± 587.19
OG003
Secondary
Low Frequency Variability of Blood Pressure Activity
Low frequency variability of systolic blood pressure will be measured using spectral analysis.
Posted
Mean
Standard Deviation
mmHg2
for 5 minutes on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)
ID
Title
Description
OG000
Amlodipine Plus Placebo/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG001
Amlodipine Plus Sitagliptin/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG002
Amlodipine Plus Sitagliptin/Aprepitant
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG003
Ramipril Plus Placebo/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
OG004
Ramipril Plus Sitagliptin/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
OG005
Ramipril Plus Sitagliptin/Aprepitant
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG006
Valsartan Plus Placebo/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG007
Valsartan Plus Sitagliptin/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG008
Valsartan Plus Sitagliptin/Aprepitant
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
Units
Counts
Participants
OG00019
OG00120
OG00220
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.14± 2.65
OG0017.32± 7.72
OG0027.07± 6.57
OG003
Secondary
Glucose
measure of effectiveness of DPP4 inhibitor
Posted
Mean
Standard Deviation
mg/dL
fasting at 3 hours on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)
ID
Title
Description
OG000
Amlodipine Plus Placebo/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG001
Amlodipine Plus Sitagliptin/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG002
Amlodipine Plus Sitagliptin/Aprepitant
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG003
Ramipril Plus Placebo/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
OG004
Ramipril Plus Sitagliptin/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
OG005
Ramipril Plus Sitagliptin/Aprepitant
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG006
Valsartan Plus Placebo/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG007
Valsartan Plus Sitagliptin/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG008
Valsartan Plus Sitagliptin/Aprepitant
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
Units
Counts
Participants
OG00032
OG00133
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG000123.78± 34.28
OG001112.51± 29.96
OG002109.08± 21.35
OG003
Secondary
Insulin
Measure of insulin resistance.
Posted
Mean
Standard Deviation
microU/mL
fasting insulin measured at 3 hours on the 7th day of each intervention (placebo, sitagliptin, sitatliptin+aprepitant)
ID
Title
Description
OG000
Amlodipine Plus Placebo/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG001
Amlodipine Plus Sitagliptin/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG002
Amlodipine Plus Sitagliptin/Aprepitant
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG003
Ramipril Plus Placebo/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
OG004
Ramipril Plus Sitagliptin/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
OG005
Ramipril Plus Sitagliptin/Aprepitant
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG006
Valsartan Plus Placebo/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG007
Valsartan Plus Sitagliptin/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG008
Valsartan Plus Sitagliptin/Aprepitant
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
Units
Counts
Participants
OG00026
OG00122
OG00221
OG003
Title
Denominators
Categories
Title
Measurements
OG00020.7± 10.36
OG00120.72± 11.95
OG00220.22± 16.32
OG003
Secondary
Dipeptidyl Peptidase IV (DPP4) Activity
Measure of DPP4 inhibitor administration.
Posted
Mean
Standard Deviation
nmol/mL/min
for 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)
ID
Title
Description
OG000
Amlodipine Plus Placebo/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG001
Amlodipine Plus Sitagliptin/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG002
Amlodipine Plus Sitagliptin/Aprepitant
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG003
Ramipril Plus Placebo/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
OG004
Ramipril Plus Sitagliptin/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
OG005
Ramipril Plus Sitagliptin/Aprepitant
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG006
Valsartan Plus Placebo/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG007
Valsartan Plus Sitagliptin/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG008
Valsartan Plus Sitagliptin/Aprepitant
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
Units
Counts
Participants
OG00033
OG00133
OG00231
OG003
Title
Denominators
Categories
Title
Measurements
OG00020.27± 6.80
OG0017.34± 2.98
OG0026.96± 4.33
OG003
Secondary
Angiotensin Converting Enzyme (ACE) Activity
This is a measure of activity of the angiotensin-converting enzyme (ACE). The assay is a kinetic assay (Labcore) that measures the rate of cleavage of an added ACE substrate over time and the results are reported in Units, which represent the rate of increase in fluorescent metabolite over 30 minutes under standard conditions at 37C.
Posted
Mean
Standard Deviation
Units
for 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)
ID
Title
Description
OG000
Amlodipine Plus Placebo/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG001
Amlodipine Plus Sitagliptin/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG002
Amlodipine Plus Sitagliptin/Aprepitant
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG003
Ramipril Plus Placebo/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
OG004
Ramipril Plus Sitagliptin/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
OG005
Ramipril Plus Sitagliptin/Aprepitant
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG006
Valsartan Plus Placebo/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG007
Valsartan Plus Sitagliptin/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG008
Valsartan Plus Sitagliptin/Aprepitant
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
Units
Counts
Participants
OG00033
OG00133
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG00037.00± 14.56
OG00140.15± 14.87
OG00235.78± 13.73
OG003
Secondary
Mean Arterial Blood Pressure
Average of measurements made every five minutes beginning just prior to (time 0) and for four hours after the ingestion of a mixed meal
Posted
Mean
Standard Deviation
mmHg
Value provided is the AVERAGE of measurements made every five minutes prior to (time 0) and for four four hours after ingestion of a mixed meal.
ID
Title
Description
OG000
Amlodipine Plus Placebo/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG001
Amlodipine Plus Sitagliptin/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG002
Amlodipine Plus Sitagliptin/Aprepitant
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG003
Ramipril Plus Placebo/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
OG004
Ramipril Plus Sitagliptin/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
OG005
Ramipril Plus Sitagliptin/Aprepitant
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG006
Valsartan Plus Placebo/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG007
Valsartan Plus Sitagliptin/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG008
Valsartan Plus Sitagliptin/Aprepitant
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG003
Title
Denominators
Categories
Title
Measurements
OG00096.0± 10.0
OG00193.6± 8.9
OG00292.9± 8.7
OG003
Secondary
Heart Rate
The average of measurements made every five minutes prior to (time 0) and for four four hours after ingestion of a mixed meal
Posted
Mean
Standard Deviation
bpm
Value provided is the average of measurements made every five minutes prior to (time 0) and for four four hours after ingestion of a mixed meal.
ID
Title
Description
OG000
Amlodipine Plus Placebo/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG001
Amlodipine Plus Sitagliptin/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG002
Amlodipine Plus Sitagliptin/Aprepitant
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG003
Ramipril Plus Placebo/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
OG004
Ramipril Plus Sitagliptin/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
OG005
Ramipril Plus Sitagliptin/Aprepitant
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG006
Valsartan Plus Placebo/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG007
Valsartan Plus Sitagliptin/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG008
Valsartan Plus Sitagliptin/Aprepitant
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG003
Title
Denominators
Categories
Title
Measurements
OG00071.8± 13.1
OG00170.3± 11.6
OG00271.7± 13.0
OG003
Secondary
Neuropeptide Y
Measurement of Neuropeptide Y (NPY) concentrations
Posted
Mean
Standard Error
pM
Neuropeptide Y concentration prior to ingestion of the mixed meal.
ID
Title
Description
OG000
Amlodipine Plus Placebo/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG001
Amlodipine Plus Sitagliptin/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG002
Amlodipine Plus Sitagliptin/Aprepitant
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG003
Ramipril Plus Placebo/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
OG004
Ramipril Plus Sitagliptin/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
OG005
Ramipril Plus Sitagliptin/Aprepitant
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG006
Valsartan Plus Placebo/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG007
Valsartan Plus Sitagliptin/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG008
Valsartan Plus Sitagliptin/Aprepitant
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.35± 0.28
OG0010.52± 0.34
OG0020.51± 0.33
OG003
Secondary
24hr Urinary Testing for Sodium
Subjects will collect 24hr urine sample and bring with to the study day for analysis
Posted
Mean
Standard Deviation
mEq
Urine was collected for sodium for 24 hrs prior to each of the study days listed below. Study days occurred after each 7-day treatment arm (placebo/placebo, sitagliptin/placebo, or sitagliptin/aprepitant) within 3 anti-hypertensive groups.
ID
Title
Description
OG000
Amlodipine Plus Placebo/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG001
Amlodipine Plus Sitagliptin/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG002
Amlodipine Plus Sitagliptin/Aprepitant
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG003
Ramipril Plus Placebo/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
OG004
Ramipril Plus Sitagliptin/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
OG005
Ramipril Plus Sitagliptin/Aprepitant
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
OG006
Valsartan Plus Placebo/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
OG007
Valsartan Plus Sitagliptin/Placebo
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
OG008
Valsartan Plus Sitagliptin/Aprepitant
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
Units
Counts
Participants
OG00029
OG00129
OG00229
OG003
Title
Denominators
Categories
Title
Measurements
OG000147.66± 69.46
OG001146.90± 74.29
OG002154.42± 61.01
OG003
Other Pre-specified
Aldosterone, Angiotensin II, and Plasma Renin Activity (PRA)
renin-angiotensin system measurements were not done because there were not significant differences in blood pressure
Not Posted
for 4.5 hours on the 7th day of each intervention
Participants
0
36
0
36
4
36
EG001
Amlodipine Alone
Subjects in this arm received calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. After 4 weeks of treatment, subjects received three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions were: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
During the first four weeks and between crossover therapies, participants received amlodipine alone.
0
36
0
36
1
36
EG002
Amlodipine Plus Sitagliptin/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
0
33
0
33
7
33
EG003
Amlodipine Plus Placebo/Placebo
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and a placebo capsule for 7 days.
0
33
0
33
4
33
EG004
Amlodipine Plus Sitagliptin/Aprepitant
Participants received amlodipine 10mg/day for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and aprepitant 125 mg/d for one day followed by 80 mg/d for a total of 7 days.
0
33
0
33
9
33
EG005
Washout Prior to Ramipril
Subjects received ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks. Subjects underwent washout prior to starting ramipril.
0
35
0
35
3
35
EG006
Ramipril Alone
Subjects received ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks.
After 4 weeks of treatment, subjects received three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions were: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
During the first four weeks and between crossover therapies, participants received ramipril alone.
0
33
0
33
3
33
EG007
Ramipril Plus Placebo/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
0
27
0
27
3
27
EG008
Ramipril Plus Sitagliptin/Placebo
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and a placebo capsule for 7 days.
0
25
0
25
1
25
EG009
Ramipril Plus Sitagliptin/Aprepitant
Participants in this group received ramipril 10mg/d for 15 days. During this intervention period they also received sitagliptin 100 mg/day and aprepitant 125 mg/d for one day followed by 80 mg/d for a total of 7 days.
0
28
0
28
4
28
EG010
Washout Prior to Valsartan
Subjects received ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. Subjects underwent washout prior to starting valsartan.
0
35
1
35
5
35
EG011
Valsartan Alone
Subjects received ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects received three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
During the first four weeks and between crossover therapies, participants received valsartan alone.
0
31
1
31
0
31
EG012
Valsartan Plus Placebo/Placebo
Participants in this group received valsartan 320 mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
0
28
0
28
4
28
EG013
Valsartan Plus Sitagliptin/Placebo
Participants in this group received valsartan 320 mg/d for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and a placebo capsule for 7 days.
0
29
0
29
5
29
EG014
Valsartan Plus Sitagliptin/Aprepitant
Participants in this group received valsartan 320 mg/d for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and aprepitant 125 mg/d for one day followed by 80 mg/d for a total of 7 days.