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Completed

NCT Number: NCT03006471

Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension

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.

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Key information

Conditions

PreDiabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State Prehypertension Vascular Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin

Drug

10 mg, one per day before breakfast during 12 weeks.

Other names: Forxiga

Placebo - Cap

Drug

one per day before breakfast during 12 weeks.

Other names: Calcined magnesium

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 30, 2016
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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