Obesity Clinical Trial
Official title:
Randomisation to Endoluminal Intestinal Liner Alone Versus With Incretin Analogue in SustainEd Diabesity (REVISE-Diabesity)
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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