Effect of Dapagliflozin on Blood Pressure Variability in Patients With Prediabetes and Prehypertension Without Pharmacological Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Daytime Systolic Blood Pressure at Week 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Dapagliflozin
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
干预措施: Dapagliflozin (Drug)
Placebo
Placebo capsules, one per day before breakfast during 12 weeks.
干预措施: Placebo - Cap (Drug)
结局指标
主要结局
Daytime Systolic Blood Pressure at Week 12
时间窗: 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
Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12
时间窗: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12
时间窗: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Daytime Diastolic Blood Pressure at Week 12
时间窗: 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
24-hours Systolic Blood Pressure at Week 12
时间窗: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
24-hours Diastolic Blood Pressure at Week 12
时间窗: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Nighttime Systolic Blood Pressure at Week 12
时间窗: 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
Nighttime Diastolic Blood Pressure at Week 12
时间窗: 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
Systolic Blood Pressure Weighted Standard Deviation at Week 12
时间窗: Week 12
Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Diastolic Blood Pressure Weighted Standard Deviation at Week 12
时间窗: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12
时间窗: 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
Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12
时间窗: 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
Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12
时间窗: 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
Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12
时间窗: 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
Average Real Variability of Systolic Blood Pressure at Week 12
时间窗: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Average Real Variability of Diastolic Blood Pressure at Week 12
时间窗: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12
时间窗: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12
时间窗: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12
时间窗: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
次要结局
- Number of Participants With Prehypertension at Week 12(Week 12)
- Number of Participants With Prediabetes Plus Prehypertension at Week 12(Week 12)
- Body Weight at Week 12(Week 12)
- Body Mass Index at Week 12(Week 12)
- Office Systolic Blood Pressure at Week 12(Week 12)
- Office of Diastolic Blood Pressure at Week 12(Week 12)
- Fasting Plasma Glucose Levels at Week 12(Week 12)
- 2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12(Week 12)
- Glycated Hemoglobin A1c (A1C) at Week 12(Week 12)
- Daytime Mean Arterial Pressure at Week 12(Week 12)
- Nighttime Mean Arterial Pressure at Week 12(Week 12)
- Daytime Hypertensive Load at Week 12(Week 12)
- Nocturnal Hypertensive Load at Week 12(Week 12)
- Number of Participants With Prediabetes at Week 12(Week 12)
研究者
Manuel González Ortiz
PhD
University of Guadalajara