REVISE-Diabesity: Randomisation to Endoluminal intestinal liner alone Versus with Incretin analogue in SustainEd Diabesity - REVISE-Diabesity

Sandwell and West Birmingham Hospitals NHS Trust0 个研究点目标入组 0 人开始时间: 2013年1月4日最近更新: 2013年2月11日

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•Patients will be eligible to be included in this randomised clinical trial if they meet the following inclusion criteria: 1. participation in ABCD Nationwide Liraglutide Audit with data for at least 6 months, 2. HbA1c =7.5% after at least 6 months’ Liraglutide treatment, 3. BMI =35 Kg/m2 (=30 Kg/m2 for Asian origin patients), 4. stable weight and HbA1c in preceding 3 months (<3 Kg reduction in weight and <0.3% reduction in HbA1c).
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 65
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 7

•Exclusion criteria will include the following: abnormal intestinal anatomy; contraindication to oesophago-gastroduoenoscopy; previous bariatric surgery or bowel surgery; active infection or CRP >10; anticoagulation therapy; 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 with active ischaemic heart disease or cerebrovascular disease or those in whom aspirin treatment should continue. Patients taking regular aspirin will need to discontinue it for the duration of the Endobarrier implantation if randomised to that arm and so for those in whom it is taken for primary prevention, the potential risks and benefits of deciding to discontinue aspirin will be weighed up by the clinician concerned in consultation with the patient.

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