Metabolic Effects of Different Surgical Methods to Treat Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 8
- 主要终点
- Insulin Sensitivity at 2 Years
研究概览
简要总结
Obese patients have an increased risk for developing severe metabolic disorders. This risk can only partly be reduced by weight reduction. The investigators have in a pilot study investigated if removal of abdominal fat (visceral) in addition to weight loss has additional beneficial effects on the metabolic profile and weight loss. This study aims to further investigate if removal of abdominal fat (major omentum) leads to beneficial metabolic effects.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Body mass index over 40 kg/m2
- •Body mass index over 35 kg/m2 with obesity associated co-morbidities such as type 2 diabetes and/or additional cardiovascular risk factors -
排除标准
- 未提供
研究组 & 干预措施
Control
Gastric bypass operation without omentectomy.
干预措施: Gastric bypass operation (Procedure)
Omentectomy
Gastric bypass operation in conjunction with removal of greater omentum
干预措施: Omentectomy (Procedure)
Omentectomy
Gastric bypass operation in conjunction with removal of greater omentum
干预措施: Gastric bypass operation (Procedure)
结局指标
主要结局
Insulin Sensitivity at 2 Years
时间窗: 2 years postoperative
Insulin sensitivity measured by hyperinsulinemic euglycemic clamp
次要结局
- Body Composition at Two Years(2 years postoperative)
- Blood Pressure at 2 Years(2 years postoperative)
- Blood Lipids(2 years postoperative)
- Body Mass Index at 2 Years(2 years postoperative)
研究者
Erik Näslund
Professor, MD, PhD
Karolinska Institutet