NCT02400099Unknown不适用
Protein-rich Diet and Non-Alcoholic Fatty Liver Disease in Bariatric Surgery
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Liver fat content assessment
研究概览
简要总结
Randomized, single-blind, trial to determine whether a high-protein, low calorie diet is more effective than a control low calorie diet in improving the metabolic and histologic abnormalities in patients with Non-alcoholic Fatty Liver Disease undergoing bariatric surgery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Morbidly obese subjects with a BMI >40 kg/m2 who are eligible for bariatric surgery and have accepted to undergo RYGB
- •Weight stable for at least 6 months before the study (+/- 5 kg within the previous 6 months)
- •Stable medication
- •Provision of informed consent
排除标准
- •Patients not eligible for laparoscopic RYGB
- •Incapacity to give a valid informed consent or unwilling to give the consent
- •Pregnancy or lactating
- •Type 2-diabetes mellitus
- •Significant illness within the two weeks preceding surgery, as judged by the physician.
- •Obvious infection (bacteria, virus etc)
- •Major cardiovascular disease
- •Major gastrointestinal, respiratory, or any hormonal disorders
- •History of drug addiction and/or alcohol use
- •Suspected or confirmed poor compliance
- •Alcohol consumption of > 20 g per day in the case of women and > 30 g per day in the case of men for at least 3 consecutive months during the previous 5 years
- •Presence of hepatitis C or frank cirrhosis.
结局指标
主要结局
Liver fat content assessment
时间窗: 1 year
次要结局
- fat free mass assessment(1 year)
- Insulin sensitivity assessment(1 year)
研究者
Geltrude Mingrone
Associate Professor
Catholic University of the Sacred Heart
研究点 (2)
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