Effect of Administration of Resveratrol on Glycemic Variability in Individuals With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Mean amplitude of glucose excursions (MAGE)
研究概览
简要总结
Type 2 diabetes mellitus [ T2DM ] has quickly become the epidemic of the XXI century and challenging global health . Estimates of the World Health Organization [ WHO ] indicate that globally , from 1995 to date has nearly tripled the number of people living with diabetes mellitus [DM ]. Resveratrol has been extensively studied as a regulator of glucose through its antioxidant effects and protecting pancreatic β cells by activation of sirtuin -1 [ SIRT1 ] dependent deacetylase nicotinamide adenine diphosphate [ NAD ]. Therefore, it is important to know the effect of resveratrol on the glycemic variability [GV ] in patients with T2DM who are not in control with metformin monotherapy based.
详细描述
The objective is to evaluate the effect of administration of resveratrol on GV in individuals with T2DM inadequately controlled on metformin, for which we will conduct a double-blind trial, randomized, placebo control group, each group 11 male and female patients 30-60 years of age with T2DM inadequately controlled with metformin [2000 mg / day and glycosylated hemoglobin A1c (A1C) ≥% 7], with body mass index [BMI] form 25.0 to 34.9 kg / m2. Randomization will determine who will receive the intervention during the 8-week trial [resveratrol capsules, 500 mg 3 times daily with the first bite of each meal or approved placebo capsules], both groups also continue with metformin. The clinical findings and laboratory tests include a metabolic profile and biosafety, which will be made at baseline and at 8 weeks. Body weight, body fat, BMI and blood pressure will be determined during the initial and final visit, likewise, plasma glucose concentrations every hour recorded over 72 hours by continuous monitoring system outpatient glucose [MACG] via iPro ™ 2 [Medtronic MiniMed, Northridge] system, through which the mean amplitude of glucose excursions [MAGE] is calculated and AUC glucose, which will serve to assess the GV. Adverse events and adherence to treatment will be documented. Statistical analysis: Mann-Whitney U test, Wilcoxon and Fisher exact test. It is considered with significance at 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
- •BMI from 25.0-34.9 kg/m2
- •Diagnosis of T2DM
- •Fasting plasma glucose >130 and <250 mg/dl at the time of scrutiny
- •A1C between 7 and 10%
- •Metformin monotherapy
- •Written informed consent
排除标准
- •Women pregnant or breastfeeding
- •Untreated thyroid disease and/or uncontrolled hypertension [≥150 systolic and diastolic ≥90]
- •Consumption of oral agents or other medications or supplements, unlike metformin, with proven properties that modify the behavior of glucose
- •Total cholesterol >400 mg/dL
- •Triglycerides ≥400 mg/dL
- •Liver enzymes [ALT and AST] more than twice the normal range
- •Glomerular filtration rate <60 mL/min [Cockcroft-Gault]
研究组 & 干预措施
Resveratrol
Individuals with T2DM inadequately controlled with metformin 2000 mg/day and A1C ≥7%.
干预措施: Resveratrol (Drug)
Placebo
Individuals with T2DM inadequately controlled with metformin 2000 mg/day and A1C ≥7%.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean amplitude of glucose excursions (MAGE)
时间窗: 56 days
Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 2
Area under the curve
时间窗: 56 days
Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 2
次要结局
- A1C(56 days)
- Low-density lipoprotein cholesterol(56 days)
- Very-low density lipoprotein(56 days)
- Body and visceral fat %(56 days)
- Postprandial glucose(56 days)
- Total cholesterol(56 days)
- Alanine aminotransferase(56 days)
- Aspartate aminotransferase(56 days)
- Creatinine(56 days)
- Blood pressure(56 days)
- Fasting plasma glucose(56 days)
- Triglycerides(56 days)
- High-density lipoprotein cholesterol(56 days)
研究者
Esperanza Martínez-Abundis
Esperanza Martínez-Abundis, FACP, PhD
University of Guadalajara