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Prediabetes is defined as an intermediate metabolic state that leads to the development of type 2 diabetes mellitus (DM2) and the prehypertension is a category assigned to identify patients who are at risk of developing hypertension (AH), in both pathologies the abnormalities in the variation of blood pressure (BP) has been related to organ damage, its evaluation is performed by ambulatory blood pressure monitoring (ABPM).
Dapagliflozin is a selective and reversible inhibitor of the sodium-glucose co-transporter type 2 (SGLT-2), which reduces renal reabsorption of glucose and promotes the excretion of glucose through the urine, in the way that glucose blood. Another reported effects is the decrease on BP, so it would be interesting to evaluate this effects in patients with prediabetes and prehypertension, as a potential therapy to treat disorders and to prevent progression to DM2 and Hypertension, respectively.
The aim of this study is to evaluate the effect of Dapagliflozin on variability of blood pressure in patients with prediabetes and prehypertension without pharmacological treatment.
The investigators hypothesis is that the administration of dapagliflozin decreases variability of blood pressure in patients with prediabetes and prehypertension without pharmacological treatment.
A randomized, double-blind, placebo-controlled clinical trial in 30 patients with a diagnosis of prediabetes and prehypertension without treatment.
They will be assigned randomly two groups of 15 patients each to receive 10 mg of Dapagliflozin (Forxiga, Astra Zeneca) or placebo, one per day before breakfast during 12 weeks.
There will be calculated body mass index (BMI) and blood pressure variability. This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.
Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2/ exact fisher test, will be used for differences inter-group Mann-Whitney U Test and coefficient of variation, Wilcoxon Test and index of variability for the within-groups differences. It will be considered statistical significance p ≤0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. |
|
| Placebo | Placebo Comparator | Placebo capsules, one per day before breakfast during 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | 10 mg, one per day before breakfast during 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hours Systolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Week 12 |
| 24-hours Diastolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Week 12 |
| Daytime Systolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 am. to 11 p.m. by oscillometric method Microlife WatchBP O3 | Week 12 |
| Daytime Diastolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to p.m. by oscillometric method Microlife WatchBP O3 | Week 12 |
| Nighttime Systolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3 | Week 12 |
| Nighttime Diastolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3 | Week 12 |
| Systolic Blood Pressure Weighted Standard Deviation at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight at Week 12 | The body weight was measured with a bioimpedance balance | Week 12 |
| Body Mass Index at Week 12 | Body Mas Index was calculated with the Quetelet index formula |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MANUEL GONZALEZ, PhD | University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Terapeútica Experimental y ClÃnica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara | Guadalajara | Jalisco | 44340 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dapagliflozin | Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. |
| FG001 | Placebo | Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dapagliflozin | Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 24-hours Systolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmHg | Week 12 |
|
Through study completion, an average of 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dapagliflozin | Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cervicovaginal infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR. MANUEL GONZALEZ ORTIZ | INSITITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA | +52 3310585200 | 34212 | uiec@prodigy.net.mx |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 9, 2016 | Sep 19, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2016 | Sep 19, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Placebo - Cap | Drug | one per day before breakfast during 12 weeks. |
|
|
Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 |
| Week 12 |
| Diastolic Blood Pressure Weighted Standard Deviation at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Week 12 |
| Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Week 12 |
| Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Week 12 |
| Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m to 11 p.m. by oscillometric method Microlife WatchBP O3 | Week 12 |
| Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3 | Week 12 |
| Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3 | Week 12 |
| Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3 | Week 12 |
| Average Real Variability of Systolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Week 12 |
| Average Real Variability of Diastolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Week 12 |
| Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Week 12 |
| Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Week 12 |
| Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Week 12 |
| Week 12 |
| Office Systolic Blood Pressure at Week 12 | Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.) | Week 12 |
| Office of Diastolic Blood Pressure at Week 12 | Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.) | Week 12 |
| Fasting Plasma Glucose Levels at Week 12 | The fasting glucose levels was evaluated with enzymatic/colorimetric techniques | Week 12 |
| 2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12 | 2-hours plasma glucose after a oral glucose tolerance test (75 g of glucose load). Glucose was evaluated with enzymatic/ colorimetric technique | Week 12 |
| Glycated Hemoglobin A1c (A1C) at Week 12 | A1C was evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA) | Week 12 |
| Daytime Mean Arterial Pressure at Week 12 | The mean arterial pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3 | Week 12 |
| Nighttime Mean Arterial Pressure at Week 12 | The Mean Arterial Pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3 | Week 12 |
| Daytime Hypertensive Load at Week 12 | The hypertensive load was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3 | Week 12 |
| Nocturnal Hypertensive Load at Week 12 | The Hypertensive Load was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to a.m. by oscillometric method Microlife WatchBP O3 | Week 12 |
| Number of Participants With Prediabetes at Week 12 | Prediabetes was diagnosed with the criteria of the American Diabetes Association. | Week 12 |
| Number of Participants With Prehypertension at Week 12 | Prehypertension was diagnosed with the criteria of the Eighth Joint National Committee. | Week 12 |
| Number of Participants With Prediabetes Plus Prehypertension at Week 12 | Criteria of the American Diabetes Association and Eighth Joint National Committee were used to diagnosed prediabetes and prehypertension. | Week 12 |
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Mexico |
|
| Body weight | The body weight was measured with a bioimpedance balance and the entered values reflect the body weight at baseline | Mean | Standard Deviation | kg |
|
| Body Mass Index | Body Mas Index was calculated with the Quetelet index formula and the entered values reflect the body mass index at baseline | Mean | Standard Deviation | kg/m^2 |
|
| Office Systolic blood pressure | The office blood pressure was measured at baseline using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.). | Mean | Standard Deviation | mmHg |
|
| Office Diastolic blood pressure | The office blood pressure was measured at baseline using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.). | Mean | Standard Deviation | mmHg |
|
| Fasting plasma glucose | The fasting glucose level was evaluated with enzymatic/colorimetric techniques at baseline | Mean | Standard Deviation | mmol/L |
|
| 2-hours plasma glucose after a oral glucose tolerance test | 2-hours glucose was evaluated with an oral glucose tolerance test (75 g of glucose load) using enzymatic/colorimetric technique at baseline | Mean | Standard Deviation | mmol/L |
|
| Glycated hemoglobin A1c (A1C) | Glycosylated hemoglobin was evaluated at baseline by ELISA technique | Mean | Standard Deviation | percentage of A1C |
|
| 24-hours Systolic Blood pressure | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | mmHg |
|
| 24-hours Diastolic Blood Pressure | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | mmHg |
|
| Daytime Systolic Blood Pressure | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | mmHg |
|
| Daytime Diastolic Blood Pressure | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | mmHg |
|
| Nightime Systolic Blood Pressure | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | mmHg |
|
| Nightime Diastolic Blood Pressure | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | mmHg |
|
| Systolic Blood Pressure weighted Standard Deviation | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure weighted Standard Deviation | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | mmHg |
|
| Coefficient of variation of 24-hours, Systolic Blood Pressure | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3. | Mean | Standard Deviation | Percentage of Coefficient of variability |
|
| Coefficient of variation of 24-hours, Diastolic Blood Pressure | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3. | Mean | Standard Deviation | Percentage of Coefficient of variability |
|
| Coefficient of variation of daytime, Systolic Blood Pressure | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | Percentage of Coefficient of variability |
|
| Coefficient of variation of daytime, Diastolic Blood Pressure | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | Percentage of Coefficient of variability |
|
| Coefficient of variation of nighttime, Systolic Blood Pressure | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | Percentage of Coefficient of variability |
|
| Coefficient of variation of nighttime, Diastolic Blood Pressure | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | Percentage of Coefficient of variability |
|
| Average real variability of Systolic Blood Pressure | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | mmHg |
|
| Average real variability of Diastolic Blood Pressure | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | mmHg |
|
| Number of Participants with a Nondipper circadian blood pressure pattern | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Count of Participants | Participants |
|
| Number of Participants with a Dipper circadian blood pressure pattern | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Count of Participants | Participants |
|
| Number of Participants with a Dipper reverse circadian blood pressure pattern | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Count of Participants | Participants |
|
| Daytime Mean Arterial Pressure | The mean arterial pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | mmHg |
|
| Nighttime Mean Arterial Pressure | The mean arterial pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | mmHg |
|
| Daytime hypertensive load | The hypertensive load was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | mmHg |
|
| Nocturnal hypertensive load | The hypertensive load was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3 | Mean | Standard Deviation | mmHg |
|
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|
|
| Primary | 24-hours Diastolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmHg | Week 12 |
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| Primary | Daytime Systolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 am. to 11 p.m. by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmHg | Week 12 |
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| Primary | Daytime Diastolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to p.m. by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmHg | Week 12 |
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| Primary | Nighttime Systolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmHg | Week 12 |
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| Primary | Nighttime Diastolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmHg | Week 12 |
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| Primary | Systolic Blood Pressure Weighted Standard Deviation at Week 12 | Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmHg | Week 12 |
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| Primary | Diastolic Blood Pressure Weighted Standard Deviation at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmHg | Week 12 |
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| Primary | Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | Percentage of Coefficient of variability | Week 12 |
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| Primary | Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | Percentage of Coefficient of variability | Week 12 |
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| Primary | Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m to 11 p.m. by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | Percentage of Coefficient of variability | Week 12 |
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| Primary | Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | Percentage of Coefficient of variability | Week 12 |
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| Primary | Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | Percentage of Coefficient of variability | Week 12 |
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| Primary | Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | Percentage of Coefficient of variability | Week 12 |
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| Primary | Average Real Variability of Systolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmHg | Week 12 |
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| Primary | Average Real Variability of Diastolic Blood Pressure at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmHg | Week 12 |
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| Primary | Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Count of Participants | Participants | Week 12 |
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| Primary | Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Count of Participants | Participants | Week 12 |
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| Primary | Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Body Weight at Week 12 | The body weight was measured with a bioimpedance balance | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | kg | Week 12 |
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| Secondary | Body Mass Index at Week 12 | Body Mas Index was calculated with the Quetelet index formula | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | kg/m^2 | Week 12 |
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| Secondary | Office Systolic Blood Pressure at Week 12 | Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.) | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmHg | Week 12 |
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| Secondary | Office of Diastolic Blood Pressure at Week 12 | Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.) | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmHg | Week 12 |
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| Secondary | Fasting Plasma Glucose Levels at Week 12 | The fasting glucose levels was evaluated with enzymatic/colorimetric techniques | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
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| Secondary | 2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12 | 2-hours plasma glucose after a oral glucose tolerance test (75 g of glucose load). Glucose was evaluated with enzymatic/ colorimetric technique | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
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|
| Secondary | Glycated Hemoglobin A1c (A1C) at Week 12 | A1C was evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA) | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | percentage of A1C | Week 12 |
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|
|
| Secondary | Daytime Mean Arterial Pressure at Week 12 | The mean arterial pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmHg | Week 12 |
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|
| Secondary | Nighttime Mean Arterial Pressure at Week 12 | The Mean Arterial Pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmHg | Week 12 |
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| Secondary | Daytime Hypertensive Load at Week 12 | The hypertensive load was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | percentage of hypertensive load | Week 12 |
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| Secondary | Nocturnal Hypertensive Load at Week 12 | The Hypertensive Load was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to a.m. by oscillometric method Microlife WatchBP O3 | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | percentage of hypertensive load | Week 12 |
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| Secondary | Number of Participants With Prediabetes at Week 12 | Prediabetes was diagnosed with the criteria of the American Diabetes Association. | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Number of Participants With Prehypertension at Week 12 | Prehypertension was diagnosed with the criteria of the Eighth Joint National Committee. | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Number of Participants With Prediabetes Plus Prehypertension at Week 12 | Criteria of the American Diabetes Association and Eighth Joint National Committee were used to diagnosed prediabetes and prehypertension. | Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Count of Participants | Participants | Week 12 |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 3 |
| 15 |
| EG001 | Placebo | Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks. | 0 | 15 | 0 | 15 | 0 | 15 |
| Urinary tract infections | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Wilcoxon (Mann-Whitney) |
| 0.582 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.220 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 1.000 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.017 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.115 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.917 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.108 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.196 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.087 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.463 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.507 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.972 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.158 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.650 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.345 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.010 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.011 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.001 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.011 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.002 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.081 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.004 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.451 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.043 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.754 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.015 |
The threshold for statistical significance was p=0.05 |
| Superiority |