NCT00450710已完成4 期
Phase IV Study of Neuroendocrine Brake Surgical Procedure for Type 2 Diabetes Mellitus
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Evaluate safety and efficacy of the ileal interposition associated with a sleeve gastrectomy and the ileal interposition associated with a diverted sleeve gastrectomy.
研究概览
简要总结
Evaluation to determine the safety of two laparoscopic procedures to control T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Male and female between 18 and 65 years.
- •BMI 25.1 - 34.
- •Type 2 diabetic patients on oral anti-diabetic agents and/or insulin treatment for a minimum of 12 months prior the enrollment.
- •Diagnosis of T2DM for at least 3 years.
- •Patient has been under routine care of hte study physician or another physician that can supply a reliable medical record for at least 3 years.
- •HbA1c >/ 7.5 documented for at least 3 months.
- •Stable weight (nor significant weight change (>3%) over the 3 months prior to enrollment.
- •Stable medication for at least one month prior to enrollment except for diabetes medications which should be stable for at least 3 months prior to enrollment.
- •Ability and willingness to return for all scheduled visits and participate in recommended parameter setting and physician recommended medical/laboratory assessments.
排除标准
- •Prior abdominal surgery, except laparoscopic cholecystectomy.
- •Taking appetite suppressant.
- •Severe eating disorders.
- •Severe pulmonary, renal or cardiac disease.
- •Obese due to a clinically diagnosed endocrine disorder.
- •Subjects with impaired liver function.
- •History of peptic ulcer disease.
- •History of malignant disease.
- •Use of prescription, over the counter or herbal weight loss products.
- •Pregnant or planning on pregnancy while enrolled in study.
结局指标
主要结局
Evaluate safety and efficacy of the ileal interposition associated with a sleeve gastrectomy and the ileal interposition associated with a diverted sleeve gastrectomy.
次要结局
- Evaluate neurohormonal effect in treating T2DM.
- Improvement or control of blood glucose levels.
- Improvement or control of comorbidities associated with T2DM.
- Hormonal effect and effect of the operations on diabetes related and total mortality.
研究者
研究点 (2)
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