A Phase II Single-Center, Prospective, Open Label Study of Safety and Efficacy, of the GI Sleeve for Pre-Surgical Weight Loss, in Type II Diabetes Patients (Cohort 06-6B Only)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- % of Excess Weight Loss (EWL)
研究概览
简要总结
The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients
详细描述
Patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. NIH panel recommendations state that even a 10% short-weight loss would greatly reduce these risks. GI Dynamics' GI Sleeve represents a viable alternative to other short-term pre-surgical weight loss methods. GI Sleeve is a device that can be implanted and removed through minimal invasive endoscopic techniques. This endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 18 to 65
- •BMI 40 to 60
- •Type II Diabetes
- •Candidates for bariatric surgery
排除标准
- •Patients with
- •hepatitis B or C
- •gastroesophageal reflux disease (GERD)
- •HIV Positive diagnosis
- •pancreatitis
- •conditions of gastrointestinal tract, such as ulcers or Crohn's
- •an infection or who are H. Pylori positive
结局指标
主要结局
% of Excess Weight Loss (EWL)
时间窗: 12 months
Percent excess weight loss (EWL) was calculated using Body Mass Index (BMI25) method: BMI25=ideal weight in kg/(height in meters)2 Ideal weight in kg = 25 x (Height in meters2) Baseline Excess weight = total weight - ideal weight % EWL = (baseline excess weight - weight loss) x 100
次要结局
- HbA1c Values at 12 Months(12 months)