Clinical Trial: Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 HT, 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.

Detailed Summary:

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); low-density lipoprotein cholesterol (LDL-c); very-low density lipoprotein (VLDL), glomerular filtration rate 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.

Sponsor: University of Guadalajara

Current Primary Outcome:

• Average blood pressure: nighttime, daytime and 24-hr [ Time Frame: Baseline to Week 12 ]
  Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hrs by oscillometric method Microlife WatchBP O3
• Systolic blood pressure, daytime, night and 24 hr [ Time Frame: Baseline to Week 12 ]
  Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hrs by oscillometric method Microlife WatchBP O3
• Diastolic blood pressure, daytime, night and 24 hr [ Time Frame: Baseline to Week 12 ]
  Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hrs by oscillometric method Microlife WatchBP O3
• Blood pressure [ Time Frame: Baseline, week 4, week 8 and week 12 ]
  Blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Categories of prehypertension: dipper o non dipper [ Time Frame: Baseline to Week 12 ]
  Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hrs by oscillometric method Microlife WatchBP O3
• Fasting glucose levels [ Time Frame: Baseline to Week 12 ]
  The fasting glucose levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
• Postprandial glucose levels [ Time Frame: Baseline to Week 12 ]
  Postprandial glucose will be evaluated at baseline and week 12 after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12
• Glycosylated hemoglobin [ Time Frame: Baseline to Week 12 ]
  Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA and the entered values reflect the glycosylated hemoglobin at week 12
• Total cholesterol [ Time Frame: Baseline to Week 12 ]
  Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12
• Triglycerides levels [ Time Frame: Baseline to Week 12 ]
  Triglycerides levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12
• High density lipoprotein (c-HDL) levels [ Time Frame: Baseline to Week 12 ]
  c-HDL levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12
• Creatinine levels [ Time Frame: Baseline to Week 12 ]
  Creatinine levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques
• Uric acid levels [ Time Frame: Baseline to Week 12 ]
  Uric acid levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques
• Body Weight [ Time Frame: Baseline, week 4, week 8 and week 12 ]
  The body weight will be measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12
• Body Mass Index [ Time Frame: Baseline, week 4, week 8 and week 12 ]
  Body Mas Index will be calculated at baseline, week 4, week 8 and week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12
• Glomerular filtration rate [ Time Frame: Baseline to Week 12 ]
  Glomerular filtration rate will be calculated at baseline and week 12 with the Cockcroft-Gault formula and the entered values reflect the Glomerular filtration rate at week 12

Original Secondary Outcome: Same as current

Information By: University of Guadalajara

Dates:
Date Received: December 13, 2016
Date Started: March 2016
Date Completion: November 2017
Last Updated: January 3, 2017
Last Verified: January 2017