NCT00965302终止不适用
Sleeve Gastrectomy vs Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Diabetes remission
研究概览
简要总结
The investigators plan to randomize mild to moderately obese (BMI 30-34.9) subjects to medical management (diet, exercise, and best medical therapy) versus sleeve gastrectomy with medical management, with a primary endpoint of diabetes remission (normal fasting glucose, off medications and insulin) at one year. Sleeve gastrectomy (also called greater curvature gastrectomy, vertical sleeve gastrectomy, and sleeve gastroplasty) involves stapled resection of the gastric fundus. Secondary endpoints include weight loss, improvement in hypertension, sleep apnea, c-reactive protein, and fasting lipid profile.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus, Type 2
- •Body Mass Index (BMI) 30-34.9
- •Able to understand and comply with study process
排除标准
- •Pregnancy
- •Prior bariatric surgery
- •Diabetes mellitus, Type 1
- •Renal impairment
- •Cirrhosis or portal hypertension
- •Diabetes secondary to a specific condition
- •Recent internal malignancy (<5 years)
- •Recent major vascular event
- •Drug or alcohol dependence
- •Uncontrolled psychiatric disease
- •Crippling cardiopulmonary disease
- •Prohibitive anatomic features (extensive prior surgery, giant paraesophageal hernia)
结局指标
主要结局
Diabetes remission
时间窗: 1 year
次要结局
- c-reactive protein(1 year)
- Fasting lipid profile(1 year)
- Weight loss(1 year)
- Obstructive sleep apnea remission(1 year)
研究者
研究点 (2)
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