Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension

October 16, 2020 updated by: Manuel González Ortiz, University of Guadalajara

Effect of Dapagliflozin on Blood Pressure Variability in Patients With Prediabetes and Prehypertension Without Pharmacological Treatment

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dapagliflozin
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
10 mg, one per day before breakfast during 12 weeks.
Other Names:
  • Forxiga
Placebo Comparator: Placebo
Placebo capsules, one per day before breakfast during 12 weeks.
one per day before breakfast during 12 weeks.
Other Names:
  • Calcined magnesium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 12
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
Week 12
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
Week 12
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
Week 12
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
Week 12
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
Week 12
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
Week 12
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
Week 12
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
Week 12
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
Week 12
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
Week 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
Week 12
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
Week 12
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
Week 12
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
Week 12
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
Week 12
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
Week 12
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
Week 12
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
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight at Week 12
Time Frame: Week 12
The body weight was measured with a bioimpedance balance
Week 12
Body Mass Index at Week 12
Time Frame: Week 12
Body Mas Index was calculated with the Quetelet index formula
Week 12
Office Systolic Blood Pressure at Week 12
Time Frame: 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
Time Frame: Week 12
Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)
Week 12
Fasting Plasma Glucose Levels at Week 12
Time Frame: 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
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
Week 12
Glycated Hemoglobin A1c (A1C) at Week 12
Time Frame: Week 12
A1C was evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA)
Week 12
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
Week 12
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
Week 12
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
Week 12
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
Week 12
Number of Participants With Prediabetes at Week 12
Time Frame: Week 12
Prediabetes was diagnosed with the criteria of the American Diabetes Association.
Week 12
Number of Participants With Prehypertension at Week 12
Time Frame: 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
Time Frame: Week 12
Criteria of the American Diabetes Association and Eighth Joint National Committee were used to diagnosed prediabetes and prehypertension.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: MANUEL GONZALEZ, PhD, University of Guadalajara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2016

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

June 29, 2018

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

December 29, 2016

First Posted (Estimate)

December 30, 2016

Study Record Updates

Last Update Posted (Actual)

November 9, 2020

Last Update Submitted That Met QC Criteria

October 16, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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