Antihypertensive Medication Exposure as Risk for Impaired... | NCT01099397

ID	Type	Description	Link
U01GM074492	U.S. NIH Grant/Contract		View source

Antihypertensive Medication Exposure as Risk for Impaired... | NCT01099397 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PEAR Participants		All participants eligible for PEAR study. Each participant will be have fasting and oral glucose tolerance test data collected.	Other: Oral glucose tolerance test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral glucose tolerance test	Other	For assessment of dysglycemia, 75 grams of glucose solution by mouth at 3 PEAR study visits for all enrolled participants: baseline, single drug therapy assessment, and dual drug therapy assessment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Diagnosed With Prediabetes or Normal Glucose, by 2 Measurements (Fasting Glucose Measurement and Glucose Measurement After a 2-hour Oral Glucose Tolerance Test [OGTT]), at Three Timepoints During Antihypertensive Treatment	A single cohort of patients was followed through participation in the parent study, PEAR, and had both fasting and 2-hour OGTT labs evaluated at three time points. At each of these time points the two methods for evaluating prediabetes were compared. Consistent with the definition for prediabetes recommended by the American Diabetes Association, a fasting glucose above 99mg/dL or 2-hour oral glucose tolerance test glucose above 139mg/dL was considered prediabetic for this study.	Baseline, 9 weeks, and 18 weeks after initiation of PEAR intervention(s)

Contacts/Locations Module

Name	Affiliation	Role
Julie A Johnson, PharmD	University of Florida	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida Department of Community Health and Family Medicine		Gainesville	Florida	32610	United States

Label	URL
Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR) ClinicalTrials website	View source

Arm/Group Information

ID	Title	Description
FG000	PEAR Sub-study Participants	All participants eligible for the PEAR study in Gainesville, FL, starting May 2009, were allowed to participate in the PEAR sub-study; participants enrolled were evaluated at three time points as part of the PEAR protocol, at baseline, 9 weeks and 18 weeks; for each participant at each time point, a fasting glucose value and 2-hour oral glucose tolerance test value was collected and compared

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00039 subjects
COMPLETED		FG00026 subjects
NOT COMPLETED		FG00013 subjects

Type	Comment	Reasons
Lost to Follow-up		FG0004 subjects
Protocol Violation		FG0004 subjects
Withdrawal by Subject		FG0005 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	PEAR Sub-study Participants	All participants eligible for the PEAR study in Gainesville, FL, starting May 2009, were allowed to participate in the PEAR sub-study

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, Categorical			Count of Participants

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

Number of Participants Diagnosed With Prediabetes or Normal Glucose, by 2 Measurements (Fasting Glucose Measurement and Glucose Measurement After a 2-hour Oral Glucose Tolerance Test [OGTT]), at Three Timepoints During Antihypertensive Treatment

A single cohort of patients was followed through participation in the parent study, PEAR, and had both fasting and 2-hour OGTT labs evaluated at three time points. At each of these time points the two methods for evaluating prediabetes were compared. Consistent with the definition for prediabetes recommended by the American Diabetes Association, a fasting glucose above 99mg/dL or 2-hour oral glucose tolerance test glucose above 139mg/dL was considered prediabetic for this study.

Only including participants with data at each time point

Posted

Number

participants

Baseline, 9 weeks, and 18 weeks after initiation of PEAR intervention(s)

ID	Title	Description
OG000	2-hour Glucose

Adverse Events Module

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	PEAR Sub-study Participants	All participants in the PEAR sub-study were evaluated by two methods at 3 time-points in the PEAR parent study

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Mariellen Moore	University of Florida	352-273-6381		marielm@ufl.edu

Condition Browse Module

ID	Term
D011236	Prediabetic State
D007333	Insulin Resistance
D006973	Hypertension

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Intervention Browse Module

ID	Term
D005951	Glucose Tolerance Test
C007853	Glucola
D000080845	Sugar-Sweetened Beverages

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Title

Denominators

Categories

Prediabetic at baseline

Title	Measurements
	OG0006 OG0018

Normal glucose at baseline

Title	Measurements
	OG00020 OG00118

Prediabetic at 9 weeks

Title	Measurements
	OG0007 OG0019

Normal glucose at 9 weeks

Title	Measurements
	OG00019 OG00117

Prediabetic at 18 weeks

Title	Measurements
	OG0007 OG0019

Normal glucose at18 weeks

Title	Measurements
	OG00015 OG00113

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Confidence Interval %	Non-Inferiority Type
OG000 OG001	p<0.05 was considered significant at baseline; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)	McNemar	McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT	0.41	P-value at baseline		Superiority or Other
OG000 OG001	p<0.05 was considered significant at 9 week assessment; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)	McNemar	McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT	0.59	P-value at 9 weeks	95	Superiority or Other
OG000 OG001	p<0.05 was considered significant at 18 week assessment; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)	McNemar	McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT	0.41	P-value at 18 weeks	95	Superiority or Other