CTRI/2013/10/004115已完成不适用
Laparoscopic Ileal Interposition with Sleeve Gastrectomy for control of Type-2 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction or Stoppage of anti-diabetic medication
研究概览
简要总结
This study is a single arm trial to evaluate efficacy of ileal interposition with sleeve gastrectomy surgery on control of type 2 diabetes mellitus. The study will be conducted at Kirloskar Hospital, Hyderabad in 30 patients. Primary outcome will be to assess reduction/stoppage of anti-diabetic medication in 3 months - 12 months. Secondary outcome will measure glycosylated hemoglobin A1C levels at 6 months & 12 months after surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed Type 2 Diabetes for 2-30 years
- •C-Peptide levels of more than 1ng/ml
- •Patients with any BMI
- •Age between 20 and 70 (both men & women included)
- •Able to provide Informed Consent.
- •Able to comply with follow-up tests and check-up.
排除标准
- •1.Pregnancy
- •Patients who have an incurable malignant or debilitating disease.
- •Serious uncorrectable impairment of coagulation (INR>1.4, PTT > + 3 secs), lungs, kidney or heart
- •Diagnosed severe eating disorder
- •Untreated endocrine disorder
- •Active peptic ulcer
- •Untreated H.
- •Cognitive Impairment.
结局指标
主要结局
Reduction or Stoppage of anti-diabetic medication
时间窗: 3, 6, 9 and 12 months
次要结局
- Glycemic Control with HbA1C 6.5(6 and 12 months)
研究者
研究点 (1)
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