Mechanisms of Type 2 Diabetes Improvement, Besides Weightloss After Gastric Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- insulin sensitivity and beta cell function
研究概览
简要总结
Proof of concept, of RYGBP and its capabilities to cure type 2 diabetes (DM 2) and sleep apnea has already been recognized in the reports on weight loss surgery.
The investigators project aims to prove that RYGBP also recovers the beta cell function (BCF) Clamp tests, the gold standard for testing IS and BCF, will be performed preoperative and early postoperatively.
Aims & methodology:
Analysis of the short-term effect of gastric bypass and sleeve gastrectomy on insulin sensitivity and beta cell function.
Preoperative baseline insulin sensitivity and beta cell function will be assessed with euglycemic and hyperglycemic clamp tests. These results will be compared with the results of the same tests carried out 3 weeks postoperative.
To determine if the duodenal exclusion is causing this effect. The results of the clamp tests 3 weeks postoperative will be compared
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male subjects aged 18 to 65
- •BMI > 35 kg/m2
- •Subject is capable and willing to give informed consent.
- •In the surgical groups indication for surgery is approved by the local multidisciplinary obesity workgroup following the NIH guidelines of
- •Patient suffers from type 2 diabetes necessitating insulin therapy.
- •Subject is a non-smoker for at least 6 months prior to study start.
- •Female patients of child bearing potential must use oral, injected or implanted hormonal methods of contraception from at least the commencement of their last normal period prior to the screening visit. Patients using hormonal contraception should use a barrier method in addition from screening visit until their next normal period following the end of the study.
- •Female patients of non-child bearing potential defined as:
- •Post-menopausal females, being amenorrhoeic for at least 1 year
- •Pre-menopausal females with a documented hysterectomy or bilateral oophorectomy.
排除标准
- •Female patient is pregnant or breastfeeding.
- •BMI < 35 kg/m2
- •Patient suffers from an endocrine disease, besides diabetes and thyroid disease, such as Cushing's disease, Addison's disease, hypothalamic tumor...)
- •Patient suffers from type 1 diabetes, MODY or LADA
- •Patient has undergone previous surgical procedure for weight loss
- •Patient is considered ASA 4 or more according to the ASA physical status classification system of the American Society of Anesthesiologists.
- •Patient suffers from liver cirrhosis
- •Patient uses steroids
- •Patient uses cyclosporin
- •Recent (<30 days) or simultaneous participation in another clinical trial.
- •Any situation that can compromise the study, including serious illness or a predictable lack of cooperation from the subject.
结局指标
主要结局
insulin sensitivity and beta cell function
时间窗: 3 weeks
insulin sensitivity and beta cell function changes 3 weeks after RYGB, sleeve gastrectomy and protein sparing diet using euglycaemic and hyperglycemic clamp techniques.
次要结局
- changes in plasma levels of gut hormones and inflammation markers(3 weeks)
研究者
Matthias Lannoo
medical doctor
University Hospital, Gasthuisberg