Effects of Resveratrol on Insulin Sensitivity, Brown Adipose Tissue and Metabolic Profile in First-degree Relatives of Type 2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 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 first-degree relatives of 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. Furthermore, in a subset of the participants the investigators want to investigate the effect of resveratrol on glucose uptake in brown adipose tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •BMI 27-35 kg/m2
- •Has first-degree relative(s) diagnosed with type 2 diabetes
- •Sedentary
- •Not more than 2 hours of sports a week
- •No active job that requires strenuous physical activity
- •Stable dietary habits: no weight gain or loss > 5kg in the last three months
- •Insulin resistant: glucose clearance rate below < 350 ml/kg/min, as determined using OGIS120
- •Willingness to abstain from resveratrol-containing food products
- •Subjects will only be included when the dependent medical doctor of this study approves participation after evaluating data obtained during screening
排除标准
- •Use of anticoagulants
- •Uncontrolled hypertension
- •Haemoglobin <7.8 mmol/l
- •In case of an abnormal ECG in rest: this will be discussed with the responsible medical doctor
- •HBA1C > 6.5%
- •Diagnosed with type 2 diabetes
- •Medication use known to interfere with glucose homeostasis/metabolism
- •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.
- •Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the intervention.
- •Participation in another biomedical study within 1 month before the first screening visit
- •Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk
- •Any contra-indication 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
- •Metal containing corpora aliena in the eye or brains
研究组 & 干预措施
placebo
A placebo will be given for 30 or 34 days (if included in brown adipose tissue measurement), 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 or 34 days (if included in brown adipose tissue measurement), 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
Hyperinsulinemic euglycemic clamp combined with indirect calorimetry: Glucose infusion rate (GIR), rate of appearance and disappearance of glucose (Ra, Rd), endogenous glucose production (EGP), oxidative and non-oxidative glucose disposal, carbohydrate and lipid oxidation, energy expenditure.
次要结局
- intrahepatic lipid content(30 days after supplementation)
- heart function(30 days after supplementation)
- intramyocellular lipid content(30 days after supplementation)
- brown adipose tissue activity(34 days after supplementation)
- muscle mitochondrial oxidative capacity (in vivo and ex vivo)(30 days after supplementation)
- intracardiac lipid content(30 days after supplementation)