Effect of Resveratrol on Insulin Resistance and Inflammatory Mediators in Obese and Type 2 Diabetic Subjects
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- NF-Kb
研究概览
简要总结
The main objective of this study is to investigate the effect of resveratrol (plant derived food supplement) on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo.
详细描述
The main objective of this study is to investigate the effect of resveratrol on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo. This research will investigate the hypothesis that resveratrol, when given orally to obese and type 2 diabetic subjects induces a decrease in reactive oxygen species (ROS) generation and the pro-inflammatory transcription factor nuclear factor-kB (NF-kB) and the inflammatory mediators regulated by it. The hypothesis that resveratrol suppresses the high fat, high carbohydrate (HFHC) meal induced inflammatory and oxidative response, will also be investigated. This research will also investigate the hypothesis that resveratrol intake for 12 weeks improves insulin sensitivity by lowering the Homeostasis model assessment of insulin resistance (HOMA-IR), an index of insulin resistance and, that resveratrol intake will cause an increase in incretins.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20 years of age and older
- •Healthy Obese subjects with BMI > 30
- •Type 2 Diabetics with BMI > 30
- •Subjects with good peripheral vein.
- •Subjects on statins, ACE inhibitors and thiazolidenediones will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study.
排除标准
- •Subjects on any antioxidant medication
- •Patient on non-steroidal anti-inflammatory drug
- •On any agent with significant antioxidant properties.
- •History of drug or alcohol abuse
- •Any life threatening disease
- •Allergy to peanuts, grapes, wine, mulberries.
- •Pregnant women.
- •Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four weeks.
- •Subjects on anticoagulants.
研究组 & 干预措施
Placebo
Placebo tablets
干预措施: Placebo (Drug)
Resveratrol 40 mg oral three times a day
Resveratrol
干预措施: Resveratrol 40 mg oral three times a day (Drug)
resveratrol 500 mg oral once daily.
Resveratrol
干预措施: Resveratrol 500 mg oral once daily. (Drug)
结局指标
主要结局
NF-Kb
时间窗: 12 weeks
To investigate the effect of resveratrol on ROS generation and the pro-inflammatory transcription factor NF-kB
次要结局
- GLP-1(12 weeks)
研究者
Paresh Dandona
MD
University at Buffalo