NL-OMON40441撤回不适用
Efficacy of Laparoscopic Roux-en-Y Gastric Bypass Surgery versus Conventional Therapy for Type 2 Diabetes Mellitus in Moderate Obese Patients with BMI of 30 -35 kg/m2: a randomized controlled trial. - ROMEO-trial
Rijnstate Ziekenhuis0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 40
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Informed consent
- •2. Age 18 * 50 years
- •3. BMI 30-35 kg/m2
- •4. Medical history of DM2
- •a. Metformin + (SU-derivate/DPP4-remmer)
- •b. Insulin dependent; with or without oral diabetic medication
- •c. GLP-1 analogue; with or without oral diabetic medication
- •5. HbA1c > 7.0% and Fasting Plasma Glucose (FPG) > 7.9 mmol/L
排除标准
- •1. No diabetes
- •2. History of bariatric surgery
- •3. C-peptide <0,27nmol/L
- •4. Enable to follow medical advises: language barrier, genetic disorders
- •5. Obesity due to medical disorder (e.g. Cushing syndrome)
- •6. Contra-indication for RYGB surgery: inflammatory bowel disease (Morbus Crohn / Colitis Ulcera)
- •7. Renal failure (MDRD < 30)
- •8. Pregnancy
- •9. Psychiatric disorder
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