CTRI/2008/091/000206未知不适用
A clinical trial of surgical treatment of Type2 Diabetes in non morbidly obese patients.
Self1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 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 sleeve gastrectomy with ileal transposition surgery on control of type 2 diabetes mellitus. The study will be conducted at Bombay Hospital, Mumbai in 100 patients. Primary outcome will be to assess reduction/stoppage of anti-diabetic medication in 3 months - 6 months. Secondary outcome will measure glycosylated hemoglobin A1C levels <6.5 at 6 months & 12 months after surgery.
研究设计
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
入选标准
- •1.Diagnosed Type 2 Diabetes for 1-5 years
- •Poorly controlled blood sugar despite standard of care as demonstrated by HbA1C 8-11 & 3 office visits
- •BMI between 23.0 and
- •Stable weight as determined by no more than a 3% change in body weight in the last 3 months.
- •Age between 25 and 65(both men & women will be included)
- •Able to provide Informed Consent.
- •Able to comply with follow-up procedures.
排除标准
- •Previous history of major abdominal surgery which may lead to a hostile abdomen.
- •Patients who have an incurable malignant or debilitating disease.4.Serious uncorrectable impairment of coagulation (INR>1.4, PTT > + 3 secs), lungs, kidney or heart5.Diagnosed severe eating disorder6.Untreated endocrine disorder7.Active peptic ulcer8.Untreated H.
- •pylori9.Cognitive Impairment10.Diabetic autonomic neuropathy11.Symptomatic gastroparesis.
结局指标
主要结局
Reduction or Stoppage of anti-diabetic medication
时间窗: 3 months & 6 months
次要结局
- Glycemic Control with HbA1C < 6.5(6 months & 12 months)
研究者
研究点 (1)
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