Randomisation to Endoluminal Intestinal Liner Alone Versus With Incretin Analogue in SustainEd Diabesity (REVISE-Diabesity)
试验速览
- 阶段
- 4 期
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Glycated haemoglobin (HbA1c)
研究概览
简要总结
New effective non-surgical treatments are needed for patients whose obesity and type 2 diabetes (T2DM) do not respond to current medical therapies. We propose a randomised controlled trial of Endobarrier, an implantable intestinal device that separates ingested food from contacting the first 60cm of intestine where sited and that mimics some of the clinical effects of bariatric surgery (improved metabolic control with weight loss) with or without continued use of the GLP-1 receptor agonist (GLP-1RA) Liraglutide 1.2mg vs Liraglutide 1.8mg without the device in obese patients with T2DM who remain with suboptimal glycaemic control despite current conventional diabetes treatment, in an NHS setting.
Seventy-two patients with T2DM and obesity (HbA1c≥7.5%, BMI≥35kg/m2) despite previous GLP-1RA therapy will be studied over 24 months and randomised to receive Endobarrier with continued Liraglutide 1.2mg for 12 months; Endobarrier alone for 12 months; or Liraglutide 1.8mg without Endobarrier.
We will investigate potential mechanisms of action and their time course as part of the study by repeated measures of: 1. insulin resistance measures, gut peptides, bile acids; 2. energy intake and nutritional composition; 3. liver fat stores, 4. intestinal inflammation and permeability measures.
The data will inform clinical use of the device and development of new treatments for T2DM and obesity.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes with latest HbA1c ≥7.5% (≥58mmol/mol)
- •obesity with latest BMI ≥35 Kg/m2 (≥30 Kg/m2 for those of South Asian origin)
- •liraglutide therapy for at least 6 months - HbA1c and weight trend data should be available
- •stable weight and HbA1c in preceding 3 months (<3 Kg reduction in weight and <0.3% reduction in HbA1c)
排除标准
- •<18 years of age
- •abnormal intestinal anatomy e.g. Crohn's disease
- •contraindication to oesophago-gastroduodenoscopy
- •previous bariatric surgery or bowel surgery
- •active infection
- •anticoagulation therapy which cannot be discontinued/ coagulopathy INR >1.3
- •eGFR <30
- •known portal hypertension
- •previous pancreatitis or amylase > 3 times the upper limit of normal
- •uncontrolled cardiovascular disease
- •lactating or pregnant females
- •patients taking aspirin in whom it should continue (e.g. active ischaemic heart disease or cerebrovascular disease)
- •excess anaesthetic risk as identified by the anaesthetist or investigator (e.g. uncontrolled obstructive sleep apnoea)
研究组 & 干预措施
Liraglutide alone
Liraglutide 1.8mg once daily subcutaneous injection
干预措施: Liraglutide (Drug)
Endobarrier alone
Duodenal-jejunal bypass liner (Endobarrier) device implantation without additional GLP-1RA therapy
干预措施: Duodenal-jejunal bypass liner - Endobarrier device (Device)
Endobarrier and Liraglutide
Duodenal-jejunal bypass liner (Endobarrier) device with combined liraglutide 1.2mg once daily subcutaneous injection
干预措施: Liraglutide (Drug)
Endobarrier and Liraglutide
Duodenal-jejunal bypass liner (Endobarrier) device with combined liraglutide 1.2mg once daily subcutaneous injection
干预措施: Duodenal-jejunal bypass liner - Endobarrier device (Device)
结局指标
主要结局
Glycated haemoglobin (HbA1c)
时间窗: 24 months
HbA1c (mmol/mol; %) at end of follow-up period compared to baseline. This will be 12 months following Endobarrier device removal which will usually be 24 months after initial the device has first been implanted (for 12 months) or 24 months from Liraglutide 1.8mg initiation.
次要结局
- Weight(24 months)
研究者
Dr Bob Ryder
Chief Investigator, Consultant Physician (Diabetes)
Sandwell & West Birmingham Hospitals NHS Trust