Overview

This trial is active, not recruiting.

Conditions type 2 diabetes, obesity, diabesity
Treatments liraglutide, duodenal-jejunal bypass liner - endobarrier device
Phase phase 4
Sponsor Sandwell & West Birmingham Hospitals NHS Trust
Collaborator Association of British Clinical Diabetologists
Start date July 2013
End date March 2017
Trial size 72 participants
Trial identifier NCT02055014, 12DIAB15, 2012-004988-42, ISRCTN00151053

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Liraglutide 1.8mg once daily subcutaneous injection
liraglutide Victoza
(Experimental)
Duodenal-jejunal bypass liner (Endobarrier) device implantation without additional GLP-1RA therapy
duodenal-jejunal bypass liner - endobarrier device EC Certificate Full Quality Assurance System: Certificate US08/5323
(Experimental)
Duodenal-jejunal bypass liner (Endobarrier) device with combined liraglutide 1.2mg once daily subcutaneous injection
liraglutide Victoza
duodenal-jejunal bypass liner - endobarrier device EC Certificate Full Quality Assurance System: Certificate US08/5323

Primary Outcomes

Measure
Glycated haemoglobin (HbA1c)
time frame: 24 months

Secondary Outcomes

Measure
Weight
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Randomisation to Endoluminal Intestinal Liner Alone Versus With Incretin Analogue in SustainEd Diabesity (REVISE-Diabesity)
Principal investigator Bob Ryder, MD FRCP
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Sandwell & West Birmingham Hospitals NHS Trust.