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

Obesity Clinical Trial

Official title:

Randomisation to Endoluminal Intestinal Liner Alone Versus With Incretin Analogue in SustainEd Diabesity (REVISE-Diabesity)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02055014
• Other study ID #: 12DIAB15
• Secondary ID: ISRCTN0015105320
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 3, 2014
• Last updated: April 25, 2016
• Start date: July 2013
• Est. completion date: March 2017

Study information

• Verified date: April 2016
• Source: Sandwell & West Birmingham Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeUnited Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabesity
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Drug:
• Liraglutide

Device:
• Duodenal-jejunal bypass liner - Endobarrier device

Locations

Country	Name	City	State
United Kingdom	Department of Diabetes, City Hospital	Birmingham
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Department of Diabetes, Guy's and St Thomas' Hospitals	London
United Kingdom	Diabetes Research Group, King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
Sandwell & West Birmingham Hospitals NHS Trust	Association of British Clinical Diabetologists

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated haemoglobin (HbA1c)	HbA1c (mmol/mol; %) at end of follow-up period compared to baseline. This will be 12 months following Endobarrier device removal which will usually be 24 months after initial the device has first been implanted (for 12 months) or 24 months from Liraglutide 1.8mg initiation.	24 months	No
Secondary	Weight	Weight (Kg) measured at end of follow-up period compared to baseline. This will be 12 months following Endobarrier device removal which will usually be 24 months after the device has first been implanted (for 12 months) or 24 months from Liraglutide 1.8mg initiation.	24 months	No

External Links

•   REVISE-Diabesity website