NCT00996294Unknown不适用
Surgical Treatment of Type 2 Diabetes Mellitus in Patients With BMI <35 kg/m2 (Italian Title: "La Terapia Chirurgica Del Diabete Mellito di Tipo 2 Nel Paziente Con BMI Inferiore a 35 kg/m2")
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2007年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Diabetes control, define by FSG and HbA1c
研究概览
简要总结
Thirty type 2 diabetic patients will be submitted to biliopancreatic diversion and 20 to gastric bypass. Subjects will be monitored during a 5 year period to assess the effects of the operations on diabetes control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Duration of diabetes ≥ 3 years
- •Poor glycemic control (i.e., HbA1c ≥ 7.5%) in spite of hypoglycemic therapy in accordance with good clinical practice (GCP)
排除标准
- •Specific contraindication to obesity surgery or biliopancreatic diversion or gastric bypass
- •Pregnancy
- •Medical conditions requiring acute hospitalisation
- •Severe diabetes complications or associated medical conditions [such as blindness, end-stage renal failure (i.e. serum creatinine >2 mg/dl), liver cirrhosis, malignancy, chronic congestive heart failure (NYHA class III and IV)]
- •Recent (within preceding 12 months) myocardial infarction, stroke or TIA
- •Unstable angina pectoris
- •Psychological conditions which may hamper patient's cooperation
- •Geographic inaccessibility
- •Any condition which, in the judgment of the Investigator, may make risky the participation in the study or bias the results
结局指标
主要结局
Diabetes control, define by FSG and HbA1c
时间窗: 1 year
次要结局
- Diabetes control defined by FSG and HbA1c(5 years)
研究者
研究点 (2)
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