CTRI/2013/01/003339尚未招募未知
Metabolic Surgery For The Treatment Of Type-II Diabetes
Global Hospitals0 个研究点目标入组 150 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male and female between 18 and 65 years.
- •BMI 25.1 - 34.9.
- •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 the 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.
- •Pregnant or planning on pregnancy while enrolled in study.
研究者
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