NCT01429506已完成不适用
Effect of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes
Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年1月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- weight loss
研究概览
简要总结
In this the investigators will be comparing the effects of Laparoscopic sleeve gastrectomy with intensive medical management on weight and metabolic parameters.
详细描述
Intensive medical management will include
- VLCD
- Physical activity
- Exenatide
- Metformin
- Insulin detemir
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetics with
- •BMI ≥ 27.5 kg/m2
- •HbA1c 7-10%
- •Age 20-70 years
排除标准
- •Prior gastric surgery
- •Pregnancy and lactation
- •renal disease (GFR < 60 ml/min)
- •Pancreatitis
- •Symptomatic gallstone disease
- •Active malignancy
- •Secondary causes of obesity ( Cushing's syndrome, uncontrolled Hypothyroidism)
- •Severe psychiatric illness
- •Allergic reaction to exenatide
研究组 & 干预措施
Sleeve gastrectomy
Active Comparator
Will undergo laparoscopic sleeve gastrectomy
干预措施: Sleeve gastrectomy (Procedure)
Intensive medical management
Active Comparator
Will receive VLCD, exenatide, metformin, insulin detemir
干预措施: Intensive medical management (Drug)
结局指标
主要结局
weight loss
时间窗: 6 months
weight loss at 6 months after the start of intervention
次要结局
- glycemic control(6 months)
研究者
Anil Bhansali
Professor, Department of endocrinology
Post Graduate Institute of Medical Education and Research, Chandigarh
研究点 (1)
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