Bariatric Surgery vs. Lifestyle Modification: Effects Against Nonalcoholic Steatohepatitis Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- NASH resolution
研究概览
简要总结
Randomized Controlled Trial comparing the effects of Bariatric Surgery vs. Lifestyle modification on NASH resolution.
详细描述
Patients with biopsy-proven NASH will be randomized to either bariatric surgery or lifestyle interventions. After 1-year follow-up a liver biopsy will be done to evaluate NASH resolution
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)
盲法说明
Blinded pathologist
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI between 30 and 45
- •with biopsy-proven NASH
- •with or without type 2 diabetes
- •that fit for bariatric surgery.
排除标准
- •borderline NASH ou cirrhosis;
- •alcohol consumption (> 20 g/day for men and > 10 g/day for women, for the last 2 years);
- •other hepatic diseases (such as viral hepatitis, autoimmune hepatitis, drug-induced hepatic disease, Wilson's disease, hemochromatosis);
- •HIV infection;
- •unable to provide informed consent;
- •previous foregut or bariatric surgery;
- •malignancy;
- •patients that unfit for bariatric surgery.
研究组 & 干预措施
Bariatric Surgery
Obese patients, BMI from 30 to 45, with or without type 2 diabetes, submitted to either laparoscopic Roux-en-Y Gastric Bypass or laparoscopic Sleeve Gastrectomy
干预措施: Bariatric Surgery (Procedure)
Lifestyle Modification
Obese patients, BMI from 30 to 45, with or without type 2 diabetes, submitted to guided diet and physical activity.
干预措施: Lifestyle modification (Behavioral)
结局指标
主要结局
NASH resolution
时间窗: 12 months
NASH resolution evaluated by liver biopsy
次要结局
未报告次要终点