Interventional Study of Effects of Ileal Interposition With Sleeve Gastrectomy for Control of Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage of Participants Having Remission of Type 2 Diabetes
研究概览
简要总结
Ileal interposition shifts a segment of ileum proximally to achieve maximal meal stimulated Glucagon-Like Peptide-1 secretion and coupled with a limited/complete sleeve gastrectomy (depending on the Body Mass Index), for Ghrelin reduction, helps in achieving good glycemic control in Type 2 Diabetes patients.
详细描述
Laparoscopically, using 6 ports, the ileum is tarnsected at 30 cms proximal to ileo-caecal junction and at 200 cms proximal to Ileo-Caecal junction;this ileal segment of 170 cms is interposed into proximal jejunum between 20-50 cms distal to Ligament of Treitz. Endo-GIA staplers and hand-sown closure was used for the 3 anastomoses. The mesenteric gaps defects were closed with 3/0 prolene sutures. Sleeve gastrectomy was done starting from antrum/body upto angle of His with a sizing bougie ranging from size 32--58 Fr.
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes (as defined by American Diabetes Association criteria)of more than 1 year duration
- •Body Mass Index 21 - 55 kg/m^2
- •Poor glycemic control (HbA1c > 8%) despite maximal use of Oral Hypoglycemic Agents and Insulin; or good control(lower HbA1c) but requiring progressively higher drug doses.
- •Gives Informed Consent for the surgery
- •Postmeal C peptide > 1.0 ng/mL
- •Age 25 - 75 years
- •Stable weight for more than 3 months
排除标准
- •Type 1 Diabetes
- •Postmeal C peptide < 1 ng/mL
- •Pregnancy
- •Significant nephropathy requiring dialysis
- •Coexisting systemic disease
- •Previous gastric or intestinal resection surgery
- •Obesity due to organic illness
结局指标
主要结局
Percentage of Participants Having Remission of Type 2 Diabetes
时间窗: One year
The number of patients who 1 year after surgery, have a normal glycated hemoglobin (HbA1c) less than 6.5% and all medication is stopped
次要结局
- Percentage of Participants Not Requiring Insulin(1 year)
- Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents(one year)
- Percentage of Participants Achieving Remission in Hypertension(1 year)