Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Total Insulin Sensitivity at Week 12.
研究概览
简要总结
The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.
Resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's also found in Polygonum cuspidatum. There is evidence that resveratrol consumption has beneficial effects on glucose and lipids metabolism, blood pressure and body weight.
The aim of this study was to evaluate the effect of resveratrol on metabolic syndrome, insulin sensitivity and insulin secretion.
The investigators hypothesis was that the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.
详细描述
A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric were evaluated after a 75 g of dextrose load.
12 received resveratrol, 500 mg, three times per day (1500 mg) before meals during 3 months.
The remaining 12 patients received placebo with the same prescription.
Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients both sexes
- •Age between 30 and 50 years
- •Metabolic Syndrome according to the IDF criteria
- •Waist circumference
- •Man ≥90 cm
- •Woman ≥80 cm
- •And two of the following criteria:
- •High density lipoprotein
- •Man ≤40 mg/dL
- •Woman ≤50 mg/dL
- •Fasting glucose ≥100 mg/dL
- •Triglycerides ≥150 mg/dL
- •Blood pressure ≥130/85 mmHg
- •Informed consent signed
排除标准
- •Women with confirmed or suspected pregnancy
- •Women under lactation and/or puerperium
- •Hypersensibility to resveratrol
- •Physical impossibility for taking pills
- •Known uncontrolled renal, hepatic, heart or thyroid diseased
- •Previous treatment for the metabolic syndrome components
- •Body Mass Index ≥39.9 kg/m2
- •Fasting glucose ≥126 mg/dL
- •Triglycerides ≥500 mg/dL
- •Total cholesterol ≥240 mg/dL
- •Low density lipoprotein (c-LDL) ≥190 mg/dL
- •Blood Pressure ≥140/90 mmHg
研究组 & 干预措施
Resveratrol
Resveratrol capsules, 500 mg, three times per day before meals during 90 days
干预措施: Resveratrol (Drug)
Placebo
Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
干预措施: Placebo (Drug)
结局指标
主要结局
Total Insulin Sensitivity at Week 12.
时间窗: Week 12
The insulin sensitivity was calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12
Fasting Glucose Levels at Week 12.
时间窗: Week 12
The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
Waist Circumference at Week 12
时间窗: Week 12
Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12
First Phase of Insulin Secretion at Week 12.
时间窗: Week 12
The first phase of insulin secretion was calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12
Triglycerides Levels at Week 12
时间窗: Week 12
The triglycerides were 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 at Week 12.
时间窗: Baseline. Week 12
The c-HDL levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12
Systolic Blood Pressure at Week 12.
时间窗: Week 12
The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12
Diastolic Blood Pressure at Week 12
时间窗: Week 12
The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12
Total Insulin Secretion at Week 12.
时间窗: Week 12
The total insulin secretion was calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12
次要结局
- Body Mass Index at Week 12(Week 12)
- Total Cholesterol at Week 12(Week 12)
- Creatinine at Week 12.(Baseline. Week 12.)
- Uric Acid at Week 12.(Week 12.)
- Weight at Week 12.(Week 12)
- Low Density Lipoproteins (c-LDL) at Week 12(Week 12)
研究者
Manuel González Ortiz
Senior Researcher
University of Guadalajara