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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
10 mg, one per day before breakfast during 12 weeks.
one per day before breakfast during 12 weeks.
Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, Mexico
24-hours Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
24-hours Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Daytime Systolic Blood Pressure at 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
Time frame: Week 12
Daytime Diastolic Blood Pressure at 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
Time frame: Week 12
Nighttime Systolic Blood Pressure at 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
Time frame: Week 12
Nighttime Diastolic Blood Pressure at 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
Time frame: Week 12
Systolic Blood Pressure Weighted Standard Deviation at Week 12
Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Diastolic Blood Pressure Weighted Standard Deviation at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Coefficient of Variation Daytime, Systolic Blood Pressure at 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
Time frame: Week 12
Coefficient of Variation Daytime, Diastolic Blood Pressure at 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
Time frame: Week 12
Coefficient of Variation Nighttime, Systolic Blood Pressure at 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
Time frame: Week 12
Coefficient of Variation Nighttime, Diastolic Blood Pressure at 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
Time frame: Week 12
Average Real Variability of Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Average Real Variability of Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Body Weight at Week 12
The body weight was measured with a bioimpedance balance
Time frame: Week 12
Body Mass Index at Week 12
Body Mas Index was calculated with the Quetelet index formula
Time frame: Week 12
Office Systolic Blood Pressure at Week 12
Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)
Time frame: Week 12
Office of Diastolic Blood Pressure at Week 12
Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)
Time frame: Week 12
Fasting Plasma Glucose Levels at Week 12
The fasting glucose levels was evaluated with enzymatic/colorimetric techniques
Time frame: Week 12
2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12
2-hours plasma glucose after a oral glucose tolerance test (75 g of glucose load). Glucose was evaluated with enzymatic/ colorimetric technique
Time frame: Week 12
Glycated Hemoglobin A1c (A1C) at Week 12
A1C was evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA)
Time frame: Week 12
Daytime Mean Arterial Pressure at 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
Time frame: Week 12
Nighttime Mean Arterial Pressure at Week 12
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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
Time frame: Week 12
Daytime Hypertensive Load at 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
Time frame: Week 12
Nocturnal Hypertensive Load at 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
Time frame: Week 12
Number of Participants With Prediabetes at Week 12
Prediabetes was diagnosed with the criteria of the American Diabetes Association.
Time frame: Week 12
Number of Participants With Prehypertension at Week 12
Prehypertension was diagnosed with the criteria of the Eighth Joint National Committee.
Time frame: Week 12
Number of Participants With Prediabetes Plus Prehypertension at Week 12
Criteria of the American Diabetes Association and Eighth Joint National Committee were used to diagnosed prediabetes and prehypertension.
Time frame: Week 12