NCT00596973撤回4 期
Phase IV Study of Surgical Treatment of Type 2 Diabetes in Non-Morbidly Obese Patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Treatment sucess based on patients' glycemic control
研究概览
简要总结
The aim of this study is to assess the short term success and feasibility of ileal transposition with sleeve gastrectomy in non-morbidly obese patients with poorly controlled Type 2 Diabetes Mellitus
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed Type 2 Diabetes for 3 to 5 years.
- •Poorly controlled blood sugar despite standard of care* as demonstrated by HbA1c 8-11 for at least 6 months and 3 office visits. Standard of care is based on the ADA (American Diabetes Association) guidelines which include nutrition, exercise, education, behavior modification and pharmacological treatment. A co-investigator endocrinologist will ensure that the above standard of care has been met.
- •BMI between 25.0 and 34.
- •Stable weight as determined by no more than a 3% change in body weight in the last 3 months.
- •Age between 35 and 65 (both men and 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
- •Serious uncorrectable impairment of coagulation (INR>1.4, PTT > + 3 secs), lungs, kidney or heart
- •Diagnosed severe eating disorder
- •Use of medication for weight loss in the last 6 months
- •Untreated endocrine disorder
- •Active peptic ulcer
- •Untreated H. pylori
- •Cognitive Impairment
- •Diabetic autonomic neuropathy
- •Symptomatic gastroparesis
结局指标
主要结局
Treatment sucess based on patients' glycemic control
时间窗: 12 Months
次要结局
未报告次要终点
研究者
研究点 (1)
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