Effect of Gastric Bypass Versus Diet on Cardiovascular Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- changes in HDL-cholesterol Baseline to 1 year HDL-cholesterol changes: baseline to 1 year
研究概览
简要总结
Objective: to assess the effect of gastric bypass on HDL-cholesterol concentration and its Apolipoprotein A4 content at 1 year following bariatric surgery in comparison with a hypocaloric diet. Secondary aim was to measure total cholesterol and triglycerides levels as well as insulin sensitivity after interventions.
Summary Background Data: Very few prospective uncontrolled studies have investigated the effects of Roux-en-Y gastric bypass (RYGB) on cardiovascular risk factors. No controlled studies had as primary goal the changes in HDL-cholesterol after gastric bypass.
Methods: Forty subjects with a BMI>40 or ≥35 kg/m2 in the presence of diabetes were enrolled.
Twenty of them were operated of RYGB while 20 received lifestyle modification suggestions and medical therapy for obesity complications (diabetes, hypertension and hyperlipidemia).
详细描述
Study design The study was an unblinded, prospective, non randomized clinical trial. Participants were recruited from referrals for treatment of morbid obesity between September 2008 and July 2009. One year follow-up was completed in September 2011.
The aim of the study related to the changes in HDL-cholesterol at 1 year after the intervention. Secondary aims were the changes in Apolipoprotein 4 (Apo4) and insulin sensitivity after the interventions.
Twenty morbidly-obese subjects (11 women and 9 men), whose 14 with normal glucose tolerance and 6 with type 2 diabetes mellitus (T2DM), have been studied before and 1, 2, 3, 6, 9 and 12 months after bariatric surgery.
Twenty morbidly-obese subjects (12 women and 8 men), 15 with normal glucose tolerance and 5 with T2DM, in the waiting list for bariatric surgery were enrolled in the protocol and underwent medical therapy for obesity complications (diabetes, hypertension and hyperlipidemia) and lifestyle modification suggestions.
Participants were eligible for inclusion if they had a BMI of 40 kg/m2 or >35 kg/m2 in presence of type 2 diabetes, were aged 30 to 60 years, and had not sustained weight loss in the previous 1 year. Exclusion criteria were a history of major abdominal or bariatric surgery, disabling cardiac or pulmonary diseases, cancer, long-term treatment with oral corticosteroids, and mental illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI =/> 35 kg/m2,
- •age 30-60 years,
- •both sexes
排除标准
- •history of major abdominal or bariatric surgery,
- •disabling cardiac or pulmonary diseases,
- •long-term treatment with oral corticosteroids, and
- •mental illness
结局指标
主要结局
changes in HDL-cholesterol Baseline to 1 year HDL-cholesterol changes: baseline to 1 year
时间窗: 1 year
次要结局
- changes in Apolipoprotein 4 (Apo4) and insulin sensitivity(1 year)
研究者
Geltrude Mingrone
Professor
Catholic University of the Sacred Heart