Randomisation to Endobarrier Alone Versus With Incretin Analogue in SustainEd Diabesity (REVISE-Diabesity)

Launched by SANDWELL & WEST BIRMINGHAM HOSPITALS NHS TRUST · Feb 3, 2014

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Eligibility criteria

• Inclusion Criteria:
• • 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)
• Exclusion Criteria:
• • \<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)