NCT00200018已完成不适用
ASSIST: Appetite Suppression Induced by Stimulation Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Mean excess weight loss and percent excess weight loss
研究概览
简要总结
The purpose of this study is to test the effect of an implanted device that stimulates the stomach on weight loss in patients suffering from obesity and type 2 diabetes.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes with HbA1c of 7.5 - 11%
- •Willing to make behavior and lifestyle modifications
- •No previous bariatric surgery (gastric bypass, gastric banding)
- •Meet additional study criteria
排除标准
- •History of substance abuse or chemical dependency with in the last 3 years
- •Prior GI surgery for morbid obesity or any gastric surgery for conditions other than obesity or diabetes
- •Severe congestive heart failure
- •Any underlying illness other than diabetes or obesity that affects gastrointestinal motility
- •Currently taking medications for weight loss
结局指标
主要结局
Mean excess weight loss and percent excess weight loss
时间窗: 12 months
次要结局
- Diabetes status and use of diabetes medication(12 months)
研究者
研究点 (2)
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