EndoBarrier TM Gastrointestinal Liner Diabetes Trial

NCT02459561 | Unknown DMC

• 1 other identifier: 14SM2015
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The management of obesity is challenging and obesity surgery is by far the most effective treatment currently available. Recent medical research indicates that it also improves the management of blood glucose levels in people with type 2 diabetes. Obesity surgery carries different risks and benefits and it is important to balance these by choosing the right procedure for each patient. Therefore new effective strategies to prevent and reduce obesity and its complications such as type 2 diabetes mellitus are needed. This study is designed to see whether a new device called the EndoBarrier Gastrointestinal Liner helps patients manage their blood sugar levels and lose weight. It is a randomised, placebo controlled trial which compares the potential of the EndoBarrier device with conventional drug therapy, diet and exercise for obesity related type 2 diabetes, and their effectiveness on metabolic state (HbA1c reduced by 20% and blood pressure below 135/85), weight loss, and quality of life. It will further evaluate whether any other conditions that may be related to obesity could become less severe and collect information about complications to determine the safety of the device. The study will also perform various measurements and tests to understand the underlying mechanism of the device. After an initial screening visit to determine patients eligibility, they will be invited for 14 subsequent visits. Patients will be randomised into either having the EndoBarrier device or standard medical therapy treatment for 12 months followed by another 12 months follow-up period. They will also be routinely seen by specialist dietitian who will provide dietetic support throughout the study.

Conditions

Overweight and Obesity; Diabetes

Keywords

Obesity; Diabetes; Overweight; Medical device; Endobarrier; Clinical trial; Diet; Exercise; Body weight; Medical therapy; Medicine; Device; Randomised; Control; Intervention; EndoBarrier Medical device

Outcome Measures

Primary Outcomes (1)

• HbA1c reduced by 20%

  To compare the EndoBarrier with conventional medical therapy, diet and exercise for obesity related type II diabetes and their effectiveness on metabolic state as defined by the International Diabetes Federation (IDF) with an HbA1c reduced by 20%.

  2 years

Secondary Outcomes (11)

• HbA1c < 6% ( or < 42 mmol/mol)

  2 years

• Blood pressure < 135/85

  2 years

• Absolute weight loss

  2 years

• Changes in gut hormones before and after the EndoBarrier device

  2 years

• Changes in gut microbiome before and after the EndoBarrier device to investigate the mechanism of the effect of the EndoBarrier.

  2 years

Study Arms (2)

EndoBarrier Arm

EXPERIMENTAL

The EndoBarrier Gastrointestinal Liner device received CE Mark for 12 months implant duration on 11 December 2009 and is a single use, minimally invasive device, used to achieve weight loss and improve Type 2 Diabetes status in subjects who are obese. The intent of the EndoBarrier Gastrointestinal Liner is to mimic portions of the standard Roux-en-Y bypass procedure. The device consists of 3 components: the implant, the delivery system, and the removal system. At study visit 4, after eight hours fasting, 80 subjects will arrive to the pre- assessment unit as part of the theatres at St. Mary's Hospital or Southampton Hospital and receive the EndoBarrier TM Gastrointestinal Liner as part of the EndoBarrier Arm Intervention.

Device: EndoBarrier TM Gastrointestinal Liner

Medical Therapy Arm

OTHER

The standard medical therapy arm will be carried out in accordance with the guidelines of the American Diabetes Association. These guidelines have been chosen as they are applicable to an International audience and thus would adhere to the current best worldwide practice that would still be likely to be relevant when the results are published following study completion. Diabetes reviews appointments with a Diabetologist/Endocrinologist will be performed with the control arm patients at visits 2, 4, 6, 7, 9, 11, 12, 13 and 15. At study visit 4, 80 subjects will arrive at Mary's Hospital or Southampton Hospital and receive the best Medical Care and dietary advice as part of the Medical Therapy Arm Interventions.

Other: Best Medical Care

Interventions

EndoBarrier TM Gastrointestinal Liner DEVICE

If subjects are randomised into the EndoBarrier Group of the trial they will receive the device for 12 months followed a 12 months follow-up period.

EndoBarrier Arm

Best Medical Care OTHER

If subjects are randomised into the Control Group of the trial they will receive best medical care and dietitian advice for 12 months followed a 12 months follow-up period.

Medical Therapy Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years (male or female)
• T2DM for at least 1 year (HbA1c 7.5-10.0% = 58-86 mmol/mol)
• On oral T2DM medications (metformin is allowed, but not required)
• BMI 30-50 kg/m2 with adequate insulin reserve as indicated with insulin C-peptide levels \> 1665 pmol/L

You may not qualify if:

• Language barrier, mental incapacity, unwillingness or inability to understand and be able to complete questionnaires
• Non-compliance with eligibility criteria
• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate or reliable contraceptive methods
• Current use of insulin
• Previous diagnosis with Type 1 DM or a history of ketoacidosis
• Requirement of NSAIDs (non-steroidal anti-inflammatory drugs) or prescription of anticoagulation therapy during the implant period
• History of iron deficiency and/or iron deficiency anaemia
• Symptomatic gallstones or kidney stones at the time of screening
• History of coagulopathy, upper gastro-intestinal bleeding conditions such as oesophageal or gastric varices, congenital or acquired intestinal telangiectasia
• Previous GI surgery that could affect the ability to place the device or the function of the implant
• History or presence of active H. pylori (if subjects are randomised into the EndoBarrier arm and have a history or presence of active H. pylori - tested during study visit 2 - they can receive appropriate treatment and then subsequently enrol into the study)
• Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
• Severe liver (AST, ALT or gGT \>4 times upper limit) or kidney failure (serum creatinine \>180mmol/l), estimated Glomerular Filtration Rate (GFR) cut-off is 60
• Severe depression, unstable emotional or psychological characteristics (indicated by Beck Depression Inventory II score \>28)
• Poor dentition and inability to adequately chew food

Sponsors & Collaborators

• Imperial College London: lead
• National Institute for Health Research, United Kingdom: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator
• Brunel University: collaborator
• University of Surrey: collaborator

Study Sites (1)

Imperial Clinical Trials Unit

London, W2 1PG, United Kingdom

Location

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Related Links

• Official Trial Website

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus; Motor Activity; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Julian Teare, Professor

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: June 2, 2015
• Study Start: March 1, 2015
• Primary Completion: October 18, 2018
• Study Completion: May 15, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)