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

Sponsor
Sandwell & West Birmingham Hospitals NHS Trust
Study ID
NCT02055014
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
  • Duodenal-jejunal bypass liner - Endobarrier device — DEVICE

Study Details

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.

Key Dates

Start date
Jul 31, 2013
Status verified
Apr 2016
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Liraglutide alone
    Liraglutide 1.8mg once daily subcutaneous injection
  • Experimental: Endobarrier alone
    Duodenal-jejunal bypass liner (Endobarrier) device implantation without additional GLP-1RA therapy
  • Experimental: Endobarrier and Liraglutide
    Duodenal-jejunal bypass liner (Endobarrier) device with combined liraglutide 1.2mg once daily subcutaneous injection

Primary Outcome Measure

Glycated haemoglobin (HbA1c) [ Time Frame: 24 months ]

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