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

April 25, 2016 updated by: Dr Bob Ryder, Sandwell & West Birmingham Hospitals NHS Trust

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B18 7QH
        • Department of Diabetes, City Hospital
      • Glasgow, United Kingdom, G0
        • Glasgow Royal Infirmary
      • London, United Kingdom, SE1
        • Department of Diabetes, Guy's and St Thomas' Hospitals
      • London, United Kingdom, SE5 9RS
        • Diabetes Research Group, King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Liraglutide alone
Liraglutide 1.8mg once daily subcutaneous injection
Drug: Liraglutide
Other Names:
  • Victoza
EXPERIMENTAL: Endobarrier alone
Duodenal-jejunal bypass liner (Endobarrier) device implantation without additional GLP-1RA therapy
Device: Duodenal-jejunal bypass liner - Endobarrier device
Other Names:
  • EC Certificate Full Quality Assurance System: Certificate US08/5323
EXPERIMENTAL: Endobarrier and Liraglutide
Duodenal-jejunal bypass liner (Endobarrier) device with combined liraglutide 1.2mg once daily subcutaneous injection
Drug: Liraglutide
Other Names:
  • Victoza
Device: Duodenal-jejunal bypass liner - Endobarrier device
Other Names:
  • EC Certificate Full Quality Assurance System: Certificate US08/5323

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated haemoglobin (HbA1c)
Time Frame: 24 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandwell & West Birmingham Hospitals NHS Trust

Collaborators

Association of British Clinical Diabetologists

Investigators

  • Principal Investigator: Bob Ryder, MD FRCP, Sandwell and West Birmingham Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ANTICIPATED)

March 1, 2017

Study Completion (ANTICIPATED)

March 1, 2017

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

February 3, 2014

First Posted (ESTIMATE)

February 4, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 26, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12DIAB15
  • ISRCTN00151053 (REGISTRY: ISRCTN)
  • 2012-004988-42 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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