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

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ClinicalTrials.gov Identifier: NCT02055014
Recruitment Status : Unknown
Verified April 2016 by Dr Bob Ryder, Sandwell & West Birmingham Hospitals NHS Trust.
Recruitment status was:  Active, not recruiting
First Posted : February 4, 2014
Last Update Posted : April 26, 2016
Sponsor:
Collaborator:
Association of British Clinical Diabetologists
Information provided by (Responsible Party):
Dr Bob Ryder, Sandwell & West Birmingham Hospitals NHS Trust

Brief 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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Obesity Diabesity Drug: Liraglutide Device: Duodenal-jejunal bypass liner - Endobarrier device Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomisation to Endoluminal Intestinal Liner Alone Versus With Incretin Analogue in SustainEd Diabesity (REVISE-Diabesity)
Study Start Date : July 2013
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Active Comparator: Liraglutide alone
Liraglutide 1.8mg once daily subcutaneous injection
Drug: Liraglutide
Other Name: Victoza

Experimental: Endobarrier alone
Duodenal-jejunal bypass liner (Endobarrier) device implantation without additional GLP-1RA therapy
Device: Duodenal-jejunal bypass liner - Endobarrier device
Other Name: 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 Name: Victoza

Device: Duodenal-jejunal bypass liner - Endobarrier device
Other Name: EC Certificate Full Quality Assurance System: Certificate US08/5323




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055014


Locations
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United Kingdom
Department of Diabetes, City Hospital
Birmingham, United Kingdom, B18 7QH
Glasgow Royal Infirmary
Glasgow, United Kingdom, G0
Department of Diabetes, Guy's and St Thomas' Hospitals
London, United Kingdom, SE1
Diabetes Research Group, King's College London
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Sandwell & West Birmingham Hospitals NHS Trust
Association of British Clinical Diabetologists
Investigators
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Principal Investigator: Bob Ryder, MD FRCP Sandwell and West Birmingham Hospitals NHS Trust

Additional Information:
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Responsible Party: Dr Bob Ryder, Chief Investigator, Consultant Physician (Diabetes), Sandwell & West Birmingham Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02055014    
Other Study ID Numbers: 12DIAB15
ISRCTN00151053 ( Registry Identifier: ISRCTN )
2012-004988-42 ( EudraCT Number )
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Keywords provided by Dr Bob Ryder, Sandwell & West Birmingham Hospitals NHS Trust:
Endobarrier
Duodenal-jejunal bypass liner
Glucagon-like peptide-1 receptor agonist
Liraglutide
Diabesity
Type 2 diabetes
Obesity
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Incretins
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists