Metabolic Surgery vs. Medical Management for Resolution of Type II Diabetes: A Prospective Group Match Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Resolution of type 2 diabetes mellitus, determined by oral glucose tolerance test.
研究概览
简要总结
Best medical management and gastric bypass surgery is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care).
详细描述
Best medical management and gastric bypass surgery are ways to treat obesity as part of regular medical care (standard of care). Best medical management is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care). But, studies suggest that diabetes gets better or goes away after gastric bypass surgery. This study is being done to find out if diabetes gets better or goes away completely after a patient has gastric bypass surgery as part of regular medical care (standard of care).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 25 to 70
- •BMI 35 or greater
- •HbA1c>6.5%
- •Stable weight
- •Stable medications
排除标准
- •Coagulopathy
- •Liver cirrhosis
- •C-peptide <1 ng/ml (off insulin)
- •Diagnosis of severe eating disorder
- •Untreated endocrine disorder
- •Use of medication for weight loss in the past 6 months
- •Use of medication for weight loss in the last 6 months (with the exception of orlistat)
- •Pregnancy
- •Coagulopathy
- •Liver cirrhosis
- •Incurable, malignant, or debilitating disease
- •Severe eating disorder
- •Use of weight loss medication in the last 6 months, with the exception of orlistat
- •Untreated endocrine disorder
- •Inability to provide informed consent
结局指标
主要结局
Resolution of type 2 diabetes mellitus, determined by oral glucose tolerance test.
时间窗: 2 years
Resolution of obesity co-morbidities including hypertension, OSA, and hyperlipidemia
时间窗: 2 years
次要结局
- Identify predictors of success with regard to improved co-morbidities and velocity of weight loss(2 years)
- Improvement in control of chronic co-morbidities(2 years)
- Improvement in glucose control(2 years)
研究者
David Bradley MD
Assistant Professor
Ohio State University