Effect of Resveratrol on Insulin Sensitivity and Metabolic Profile in Type 2 Diabetics
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- insulin sensitivity (overall, muscle- and liver specific)
研究概览
简要总结
The main objective of the study is to investigate if resveratrol supplementation can improve overall and muscle-specific insulin sensitivity in type 2 diabetic patients.
As a secondary objective the investigators want to investigate whether the improved insulin sensitivity can be attributed to improved muscle mitochondrial oxidative capacity and a reduced intrahepatic and cardiac lipid content.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age: 40-70 years
- •Body fat percentage > 25, BMI 27-35 kg/m2
- •Diagnosed with type 2 diabetes at least one year before the start of the study
- •Well-controlled type 2 diabetics: HBA1C < 8.0%
- •Oral glucose lowering medication (metformin only or in combination with sulfonylurea agents)
- •Sedentary
- •Not more than 2 hours of sports a week
- •No active job that requires strenuous physical activity
- •Stable dietary habits
- •Willingness to abstain from resveratrol-containing food products
排除标准
- •Unstable body weight (weight gain or loss > 3kg in the last three months)
- •Total body fat percentage < 25%
- •Hemoglobin < 7.8 mmol/l
- •Use of anticoagulants
- •Engagement in programmed exercise > 2 hours total per week
- •Impaired kidney and/or hepatic function Creatinine 50-100 umol/L Liver enzymes, within 2 times of normal range of laboratory standard (ASAT < 60 U/L, ALAT < 70 U/L, Billi <40 umol/L, gamma-GT < 80 U/L)
- •No diabetes related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy
- •Insulin dependent Diabetic subjects
- •Any medical condition except type 2 diabetes mellitus requiring treatment and/or medication use except metformin only or in combination with sulfonylurea agents
- •Intake of dietary supplements except multivitamins and minerals
- •Current alcohol consumption > 20 grams/day
- •Subjects who don't want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed, cannot participate in the study.
- •Participation in another biomedical study within 1 month before the first screening visit
- •Any contraindication to MRI scanning. These contra-indications include patients with following devices:
- •Central nervous system aneurysm clip
- •Implanted neural stimulator
- •Implanted cardiac pacemaker of defibrillator
- •Cochlear implant
- •Insulin pump
- •Or metal containing corpora aliena in the eye or brains
研究组 & 干预措施
placebo
A placebo will be given for 30 days, twice daily. One pill will be provided with lunch and the other pill will be provided with dinner.
干预措施: placebo (Dietary Supplement)
resveratrol
resveratrol will be given for 30 days, twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill of 75 mg will be provided with dinner. So in total 150 mg/day of resveratrol will be given.
干预措施: resveratrol (Dietary Supplement)
结局指标
主要结局
insulin sensitivity (overall, muscle- and liver specific)
时间窗: 30 days after supplementation
次要结局
- muscle mitochondrial oxidative capacity(30 days after supplementation)
- intramyocellular lipid content(30 days after supplementation)
- intracardiac lipid content(30 days after supplementation)
- heart function(30 days after supplementation)
- intrahepatic lipid content(30 days after supplementation)