NL-OMON50364招募中不适用
The effects of the Laparoscopic Roux-en-Y Gastric Bypass and the Laparoscopic Mini Gastric Bypass on the remission of type 2 Diabetes Mellitus and the pathophysiological mechanisms that drive the conversion of malign to benign obesity - DIABAR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
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
- •Age >=18 and <=65 years
- •BMI >=35 at the day of the intake on the bariatric ward and <=50 kg/m2 on the day
- •Diagnosis and (starting of) treatment of T2DM at intake at bariatric ward with
- •anti-diabetic medication
- •American Society of Anaesthesiologist Classification (ASA) <=3
- •All patients are required to lose 6 kilograms of weight prior to surgery
排除标准
- •Known genetic basis for insulin resistance or glucose intolerance
- •Prior Bariatric surgery
- •Patients requiring a concomitant intervention (such as cholecystectomy, ventral
- •hernia repair)
- •Auto-immune gastritis
- •Known presence of gastro-esophageal reflux disease confirmed by endoscopic
- •investigation or the use of proton-pump inhibitor indicated by complaints of
- •gastro-esophageal reflux (i.e. not indicated by polyfarmacia).
- •Known presence of large hiatal hernia requiring concomitant surgical repair
- •Coagulation disorders (PT time > 14 seconds, aPTT ((dependent on laboratory
- •methods) or known presence of bleeding disorders (anamnestic))
- •Known presence of hemoglobinopathy
- •Uncontrolled hypertension (RR > 150/95 mmHg)
- •Renal insufficiency (creatinine > 150 umol/L)
- •Breastfeeding
- •Alcohol or drug dependency
- •Patients who are considered incapable to fully understand the study and
- •implications of participation in the study, as a consequence of a language
- •barrier, psychiatric disease or mental disabilities, as judged by the surgeon
- •or the coordinating researcher
- •Participation in any other (therapeutic) study that may influence primary or
- •secondary outcomes, Notably, patients that use vitamin K antagonists or
- •non-vitamin K antagonist oral anticoagulants (i.e. NOACs (Factor Xa
- •inhibitors)) and in whom peri-operative bridging with a therapeutic dose of
- •heparin is indicated, will not undergo intra-operative tissue and/or portal
- •vein sampling.
研究者
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