NCT01826279Unknown不适用
Short-term Investigation of Resveratrol on Lipid Turnover in Morbidly Obese Women Undergoing Gastric Bypass Surgery. Effects on Basal and Insulin Stimulated FFA and VLDL-triglyceride Metabolism and Liver VLDL-triglyceride Uptake.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance
研究概览
简要总结
The purpose of this study is to investigate potential metabolic effects of resveratrol in morbidly obese women undergoing gastric bypass surgery.
The investigators hypothesize that resveratrol will:
- Decrease hepatic very-low-density-lipoprotein-triglyceride (VLDL-TG) secretion
- Decrease hepatic and adipose tissue VLDL-TG uptake
- Increase insulin sensitivity
The investigators will look at changes in:
- Lipid turnover (VLDL-TG kinetics, palmitate kinetics,calorimetry)
- VLDL-TG uptake in different tissues (subcutaneous femoral adipose tissue, subcutaneous abdominal adipose tissue, visceral adipose tissue and liver tissue)
- Insulin sensitivity (glucose kinetics during hyperinsulinaemic euglycaemic clamp)
- Regulation of liver fat handling
- Lipoprotein lipase activity and fat cell size (abdominal and femoral adipose tissue)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •25-60 years
- •Obesity (BMI > 35 kg/m2)
- •Have at least one element of the metabolic syndrome either hypertension and/or hypercholesterolemia (high triglyceride, low HDL-cholesterol)
- •Undergoing gastric bypass surgery
- •Written informed consent
排除标准
- •Any other relevant disease (e.g. diabetes, thyroid or parathyroid disease, heart, kidney or liver disease)
- •May have arthrosis or depression
- •Any present or previous malignancy
- •History of smoking
- •Alcohol dependency (more than 14 units of alcohol per week)
- •Participation in studies with radioactive isotope within the last six months
- •Hemoglobin under the normal range regarding to sex (under 7.3 mmol/l for women)
结局指标
主要结局
Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance
时间窗: 1 month
- changes from baseline after treatment with either resveratrol or placebo
Hepatic and adipose VLDL-TG uptake
时间窗: 1 month
- changes in VLDL-TG uptake in resveratrol group and placebo group
次要结局
- Basal and insulin stimulated free fatty acid (FFA) and glucose turnover(1 month)
- VLDL-TG oxidation(1 month)
- Regulation of liver fat handling(1 month)
研究者
研究点 (2)
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