NCT01025856已完成不适用
Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With Type 2 Diabetes
Federico II University0 个研究点目标入组 45 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- Liver fat content
研究概览
简要总结
The aim of this study will be to evaluate in patients with type 2 diabetes the effects on liver fat of an intervention with a diet relatively rich in CHO/rich in fibre/low GI or a diet rich in MUFA, either combined or not with a structured program of physical exercise, with emphasis on mechanisms possibly underlining these effects, namely changes in postprandial triglyceride-rich lipoproteins, body fat distribution, insulin sensitivity, oxidative stress and inflammation, adipose tissue lipolytic activities, aerobic capacity and endothelial function.
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
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and postmenopausal women
- •Age 35-65 years
- •BMI 27- 34 kg/m2
- •HbA1c <8%
- •Fasting plasma cholesterol <250 mg/dl
- •Fasting plasma triglycerides <300 mg/dl
排除标准
- •Hypolipidemic drugs
- •Plasma creatinine >1.7 mg/dl transaminases > 2 norma values
- •Ischemic heart disease or positive treadmill stress test
- •High intensity regular physical activity
- •Any disease or chronic or/and acute condition contraindicating physical activity(anaemia, and infectious, neoplastic, neurological and osteoarticular diseases).
结局指标
主要结局
Liver fat content
时间窗: 0 and 8 weeks
postprandial lipids metabolism
时间窗: 0 and 8 weeks
次要结局
- changes in body fat distribution(0 and 8 weeks)
- oxidative stress and inflammation(0 and 8 weeks)
- adipose tissue lipolytic activities(0 and 8 weeks)
研究者
rivellese angela
PA
Federico II University
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