NCT00534547撤回不适用
Phase IV Study of Duodenal Exclusion for the Treatment of Type 2 Diabetes (T2DM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Treatment success based on patients' glycemic control
研究概览
简要总结
The purpose of this study is to investigate the role of an experimental surgery that may offer better short and long-term control of T2DM in select patients who have not achieved adequate blood sugar control with regular means.
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 50 years old;
- •BMI between 27 and 34.9;
- •Oral agents or insulin to control T2DM;
- •Inadequate control of diabetes as defined as HbA1c>8.0% but <10%
- •Understanding of the mechanisms of action of the treatment
排除标准
- •More than 5 years of T2DM diagnosis;
- •C-peptide <1pg/ml (off insulin)
- •Previous abdominal operations;
- •History of gastritis
- •History of GERD
- •History of peptic ulcer disease
- •Inflammatory bowel disease
- •Coagulopathy;
- •Liver cirrhosis;
- •Unable to comply with study requirements, follow-up schedule or give valid informed consent;
- •Currently pregnant (pregnancy test required for confirmation for those of child bearing years)
- •Patient is not available for programmed follow-up during the study period
- •Patient is unwilling to forgo good samaritan blood donation during the study period
结局指标
主要结局
Treatment success based on patients' glycemic control
时间窗: 12 Months
次要结局
- Physiologic Measurements, Comorbidity improvement, Improvement in QOL(12 Months)
研究者
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