NCT01638780Unknown不适用
Effect of Resveratrol on Insulin Sensitivity and Metabolic Profile in Type 2 Diabetics
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 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
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
- intramyocellular lipid content(30 days after supplementation)
- intracardiac lipid content(30 days after supplementation)
- heart function(30 days after supplementation)
- muscle mitochondrial oxidative capacity(30 days after supplementation)
- intrahepatic lipid content(30 days after supplementation)
研究者
研究点 (2)
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