Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Diabetes control as defined by FSG and HbA1c
研究概览
简要总结
A previous prospective study of BPD effect on type 2 diabetes patients with BMI 25-35 (DIA-CHIR) showed that T2DM is less sensitive to BPD beneficial effect in the simply overweight patients. A new prospective study was then planned with the aim to gain insight in the mechanism of action of BPD in T2DM patients in the 25-30 BMI range. Thirty patients will be submitted to BPD and compared with 10 nonoperated controls. Euglycemic-hyperinsulinemic clamp, OGTT, and mixed meal test will be performed in all subjects preoperatively, and 1 month, 1 year, and 5 years after BPD. Complete clinical and biochemical evaluations will be performed at 1, 4, 8, and 12 months, and every sixth month thereafter until the end of the fifth year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •age: 35-70 years
- •diabetes duration: >5 years
- •documented poor glycemic control (HbA1c =>8% despite medical treatment according to GCP)
- •presence of comorbidities or complications (e.g. dyslipidemia, arterial hypertension, neuropathy, retinopathy, CVD, previous stroke or TIA, lower limb amputation)
- •availability to comply with the entire follow-up
排除标准
- •general contraindications to BPD (applies also to medical controls)
- •presence of anti-islet or anti-GAD antibodies or plasma C-peptide concentration <0.5 mcg/L
- •blindness
- •severe concomitant medical conditions (e.g. liver cirrhosis, renal failure, collagen diseases, severe endocrinopathies)
- •heart failure
- •recent history (less than 12 months) of myocardial infarction, stroke or TIA
- •unstable angina
- •pregnancy
- •previous or concomitant malignancy
- •severe active inflammatory, neurologic, or cardiovascular conditions
- •geographic inaccessibility
- •any condition which, in the opinion of the Principal Investigator, may make risky the participation in the study or bias the results
研究组 & 干预措施
surgery
biliopancreatic diversion
干预措施: biliopancreatic diversion (Procedure)
standard medical care
patients treated according to the rules of good clinical practice
干预措施: antidiabetics (Drug)
结局指标
主要结局
Diabetes control as defined by FSG and HbA1c
时间窗: 1 year
次要结局
- Diabetes control as defined by FSG and HbA1c(5 years)
- Assessment of prevalence and severity of diabetes complications(5 years)
- Assessment of patient BMI(5 years)