CHANGE Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- T2DM remission rate
研究概览
简要总结
Surgery is one of the management options for type 2 diabetes in patients with moderate obesity. This is a recent option because it has been part of the recommendations since October 2022.
The possible surgical techniques are the same as those for bariatric surgery:
- Sleeve,
- Bypass,
- Gastric band, but the main goal is not weight loss, it is remission of type 2 diabetes. It is called metabolic surgery.
The ring technique (gastroplasty) is practiced less and less in France because it is less effective in weight loss and is responsible for major discomfort.
Currently, metabolic surgery is one of the recommendations but no study has compared the effectiveness of the techniques with each other. One or other of the techniques can be chosen according to the preferences of the surgeon, the patient, the center, etc. but this choice is not made objectively, in the absence of comparative data.
This study would like to follow up on patients for whom metabolic surgery has been proposed by the doctor,.
If the surgery is accepted, this study would like to improve knowledge of the effectiveness of the different techniques, and thus demonstrate which metabolic surgery technique is preferred in terms of effectiveness and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patient and ≤ 65 years old
- •T2D patient, with individualized glycemic objectives not achieved, despite medical care, in particular diabetological and nutritional, also including adapted physical activity, well conducted according to current good practice recommendations, for at least twelve months
- •BMI between 30 and 34.9 kg/m²
- •patient well informed beforehand about metabolic surgery and the study
- •multidisciplinary evaluation (including a diabetologist) and decision on medical treatment by CM (date prior to inclusion)
- •medical assessment of an acceptable surgical risk
- •patient affiliated to or beneficiary of a social security system
- •patient having freely signed the written informed consent
排除标准
- •severe cognitive or mental disorders
- •severe and unstabilized eating behavior disorders
- •dependence on alcohol and licit and illicit psychoactive substances
- •illnesses endangering life in the short and medium term
- •contraindications to general anesthesia
- •absence of identified prior medical care and foreseeable inability of the patient to participate in lifelong medical monitoring
- •history of bariatric surgery
- •pregnant or breastfeeding woman, or having a very long-term pregnancy plan short term (< 2 years)
- •adult patient under guardianship or curatorship
- •patient deprived of liberty or under judicial decision
结局指标
主要结局
T2DM remission rate
时间窗: 1 year after surgery
HbA1c lower than 6.5% in the absence of antidiabetic treatment, partial, complete, prolonged remission or no remission between the 2 surgical techniques
次要结局
未报告次要终点