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Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03006471
Recruitment Status : Completed
First Posted : December 30, 2016
Results First Posted : October 19, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Manuel González Ortiz, University of Guadalajara

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
PreDiabetes Prehypertension Drug: Dapagliflozin Drug: Placebo - Cap Phase 4

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Dapagliflozin on Blood Pressure Variability in Patients With Prediabetes and Prehypertension Without Pharmacological Treatment
Actual Study Start Date : March 30, 2016
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : June 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: Dapagliflozin
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Drug: Dapagliflozin
10 mg, one per day before breakfast during 12 weeks.
Other Name: Forxiga

Placebo Comparator: Placebo
Placebo capsules, one per day before breakfast during 12 weeks.
Drug: Placebo - Cap
one per day before breakfast during 12 weeks.
Other Name: Calcined magnesium




Primary Outcome Measures :
  1. 24-hours Systolic Blood Pressure at Week 12 [ Time Frame: Week 12 ]
    Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  2. 24-hours Diastolic Blood Pressure at Week 12 [ Time Frame: Week 12 ]
    Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  3. Daytime Systolic Blood Pressure at Week 12 [ Time Frame: 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

  4. Daytime Diastolic Blood Pressure at Week 12 [ Time Frame: 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

  5. Nighttime Systolic Blood Pressure at Week 12 [ Time Frame: 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

  6. Nighttime Diastolic Blood Pressure at Week 12 [ Time Frame: 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

  7. Systolic Blood Pressure Weighted Standard Deviation at Week 12 [ Time Frame: Week 12 ]
    Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  8. Diastolic Blood Pressure Weighted Standard Deviation at Week 12 [ Time Frame: Week 12 ]
    Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  9. Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12 [ Time Frame: Week 12 ]
    Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  10. Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12 [ Time Frame: Week 12 ]
    Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  11. Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12 [ Time Frame: 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

  12. Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12 [ Time Frame: 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

  13. Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12 [ Time Frame: 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

  14. Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12 [ Time Frame: 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

  15. Average Real Variability of Systolic Blood Pressure at Week 12 [ Time Frame: Week 12 ]
    Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  16. Average Real Variability of Diastolic Blood Pressure at Week 12 [ Time Frame: Week 12 ]
    Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  17. Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12 [ Time Frame: Week 12 ]
    Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  18. Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12 [ Time Frame: Week 12 ]
    Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  19. Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12 [ Time Frame: Week 12 ]
    Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3


Secondary Outcome Measures :
  1. Body Weight at Week 12 [ Time Frame: Week 12 ]
    The body weight was measured with a bioimpedance balance

  2. Body Mass Index at Week 12 [ Time Frame: Week 12 ]
    Body Mas Index was calculated with the Quetelet index formula

  3. Office Systolic Blood Pressure at Week 12 [ Time Frame: Week 12 ]
    Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)

  4. Office of Diastolic Blood Pressure at Week 12 [ Time Frame: Week 12 ]
    Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)

  5. Fasting Plasma Glucose Levels at Week 12 [ Time Frame: Week 12 ]
    The fasting glucose levels was evaluated with enzymatic/colorimetric techniques

  6. 2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12 [ Time Frame: Week 12 ]
    2-hours plasma glucose after a oral glucose tolerance test (75 g of glucose load). Glucose was evaluated with enzymatic/ colorimetric technique

  7. Glycated Hemoglobin A1c (A1C) at Week 12 [ Time Frame: Week 12 ]
    A1C was evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA)

  8. Daytime Mean Arterial Pressure at Week 12 [ Time Frame: 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

  9. Nighttime Mean Arterial Pressure at Week 12 [ Time Frame: 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

  10. Daytime Hypertensive Load at Week 12 [ Time Frame: 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

  11. Nocturnal Hypertensive Load at Week 12 [ Time Frame: 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

  12. Number of Participants With Prediabetes at Week 12 [ Time Frame: Week 12 ]
    Prediabetes was diagnosed with the criteria of the American Diabetes Association.

  13. Number of Participants With Prehypertension at Week 12 [ Time Frame: Week 12 ]
    Prehypertension was diagnosed with the criteria of the Eighth Joint National Committee.

  14. Number of Participants With Prediabetes Plus Prehypertension at Week 12 [ Time Frame: Week 12 ]
    Criteria of the American Diabetes Association and Eighth Joint National Committee were used to diagnosed prediabetes and prehypertension.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent signed
  • Patients both sexes, age between 30 and 60 years
  • Diagnosis of prediabetes according American Diabetes Association criteria (fasting blood glucose levels between 100-126 mg/dl; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl; or glycosylated hemoglobin between 5.7-6.4%)
  • Diagnosis of prehypertension according (JNC8) Eighth Joint National Committee blood pressure between 120-139/ 80-89 mmHg.

Exclusion Criteria:

  • Women with confirmed or suspected pregnancy
  • Women under lactation and/or puerperium
  • Hypersensibility to ingredients of intervention
  • Physical impossibility for taking pills
  • Known uncontrolled renal, hepatic, heart or thyroid diseased
  • Diabetes diagnosis
  • Previous treatment for glucose or blood pressure Triglycerides ≥400 mg/dL
  • Total cholesterol ≥240 mg/dL
  • History of cardiovascular disease
  • Worker per shift / night

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006471


Locations
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Mexico
Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
University of Guadalajara
Investigators
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Principal Investigator: MANUEL GONZALEZ, PhD University of Guadalajara
  Study Documents (Full-Text)

Documents provided by Manuel González Ortiz, University of Guadalajara:
Informed Consent Form  [PDF] June 9, 2016

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Responsible Party: Manuel González Ortiz, PhD, University of Guadalajara
ClinicalTrials.gov Identifier: NCT03006471    
Other Study ID Numbers: DAPA-BP variability
First Posted: December 30, 2016    Key Record Dates
Results First Posted: October 19, 2020
Last Update Posted: November 9, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manuel González Ortiz, University of Guadalajara:
Prediabetes
Prehypertension
Variability of blood pressure
ABPM
Dapagliflozin
SGLT2
Additional relevant MeSH terms:
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Prehypertension
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Vascular Diseases
Cardiovascular Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs