Clinical trial NCT03006471: Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension
Official title: Effect of Dapagliflozin on Blood Pressure Variability in Patients With Prediabetes and Prehypertension Without Pharmacological Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PreDiabetes
Prehypertension
Keywords: Prediabetes
Prehypertension
Variability of blood pressure
ABPM
Dapagliflozin
SGLT2
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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 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.

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.

Eligibility 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

Primary outcomes:
measure: 24-hours Systolic Blood Pressure at Week 12
timeFrame: Week 12
measure: 24-hours Diastolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Daytime Systolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Daytime Diastolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Nighttime Systolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Nighttime Diastolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Systolic Blood Pressure Weighted Standard Deviation at Week 12
timeFrame: Week 12
measure: Diastolic Blood Pressure Weighted Standard Deviation at Week 12
timeFrame: Week 12
measure: Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Average Real Variability of Systolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Average Real Variability of Diastolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12
timeFrame: Week 12
measure: Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12
timeFrame: Week 12
measure: Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Body Weight at Week 12
timeFrame: Week 12
measure: Body Mass Index at Week 12
timeFrame: Week 12
measure: Office Systolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Office of Diastolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Fasting Plasma Glucose Levels at Week 12
timeFrame: Week 12
measure: 2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12
timeFrame: Week 12
measure: Glycated Hemoglobin A1c (A1C) at Week 12
timeFrame: Week 12
measure: Daytime Mean Arterial Pressure at Week 12
timeFrame: Week 12
measure: Nighttime Mean Arterial Pressure at Week 12
timeFrame: Week 12
measure: Daytime Hypertensive Load at Week 12
timeFrame: Week 12
measure: Nocturnal Hypertensive Load at Week 12
timeFrame: Week 12
measure: Number of Participants With Prediabetes at Week 12
timeFrame: Week 12
measure: Number of Participants With Prehypertension at Week 12
timeFrame: Week 12
measure: Number of Participants With Prediabetes Plus Prehypertension at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: MANUEL GONZALEZ, PhD
role: PRINCIPAL_INVESTIGATOR
References: