Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 218
- 试验地点
- 2
- 主要终点
- Time to achieve a 25% reduction in Body Mass Index
研究概览
简要总结
It is a prospective randomized trial on 218 subjects, 109 for each arms. The purpose of this trial is to compare very low calorie diet and metabolic surgery induced weight loss and its maintenance.
详细描述
Obesity is a leading public health issued associated with poor quality of life, morbidity and an increased mortality rate. Although metabolic surgery results in a greater weight loss when compared to non-surgical approaches, a low calorie diet associated with intensive maintenance session may be a valid alternative for weight loss. Since lifestyle interventions are safer and potentially more cost effective than metabolic surgery, this trial will test whether an intensive lifestyle intervention is as effective as metabolic surgery to induce weight loss and its maintenance.
A total of 218 participants will be randomly assigned to metabolic surgery (109) or intensive lifestyle intervention (109).
Clinical outcomes will be assessed at 25% reduction in Body Mass Index (BMI), at 12 months and 24 months.
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
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 19 and 69 years
- •Body Mass Index ≥35 kg/m2 and at least one or more obesity-related co-morbidities such as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease
- •Body Mass Index ≥40 kg/m2
排除标准
- •Pregnancy
- •Active cancer
- •End stage renal failure
- •End stage liver failure
- •Being unable to understand and sign informed consent
结局指标
主要结局
Time to achieve a 25% reduction in Body Mass Index
时间窗: 1-12 months
次要结局
- Time to achieve 25% reduction in Body Mass Index(1-24months)
- Change in blood pressure, from baseline, at 12 and 24 months follow up(1-24months)
- Change in triglycerides from baseline, at 12 and 24 months follow up(1-24months)
- Percentage of participants who maintain weight loss at 24 months follow up(1-24months)
- Percentage of participants who achieve 25% reduction in Body Mass Index(1-12 months)
- Change in total, HDL, LDL and total cholesterol from baseline, at 12 and 24 months follow up(1-24months)
- Change in glycated hemoglobin (HbA1c), from baseline, at 12 and 24 months follow up (patients with diabetes)(1-24months)
- Change in body composition (lean mass-all tissues in the body except bone and fat-fat mass, bone density and visceral fat) using dual energy X-ray absorptiometry (DXA), from baseline, at 25% weight loss, at 12 months follow up and at 24 months follow up(1-24months)
- Change in fasting glucose and fasting insulin, from baseline, at 12 and 24 months follow up(1-24months)
- Change in insulin resistance (assessed by HOMA-IR), from baseline, at 12 and 24 months follow up(1-24months)
研究者
Geltrude Mingrone
Professor
Catholic University of the Sacred Heart