EndoBarrier® Gastrointestinal Liner Diabetes Trial
| ISRCTN | ISRCTN30845205 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30845205 |
| ClinicalTrials.gov number | NCT02459561 |
| Secondary identifying numbers | 17212 |
- Submission date
- 26/09/2014
- Registration date
- 26/09/2014
- Last edited
- 15/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
The management of type 2 diabetes is challenging. Life-long medical therapy and changes in lifestyle (diet and exercise) are poorly accepted by most patients. Therefore, new options for diabetes treatment are required. Patients with type 2 diabetes who undergo obesity surgery (e.g. gastric bypass) see improvements in their blood sugar levels within days (and before they lose weight). However, obesity surgery is rarely used as a treatment for type 2 diabetes because of its expense and risks. This study is designed to see whether a new device called the EndoBarrier, a 60 cm long impermeable sleeve-like device inserted into the intestine, helps patients manage their blood sugar levels, lose weight and reduce other conditions related to obesity compared to standard medical therapy. The EndoBarrier device does not require surgery, yet the device appears to provide similar benefits to patients in terms of improving their blood glucose control. The EndoBarrier device also appears to help people to lose weight and is therefore useful in the treatment of obesity and other health problems related to being overweight e.g. high blood pressure. The purpose of this study is to see how effective the EndoBarrier is compared to standard medical care for diabetes treatment and weight loss and also to better understand the ways in which the EndoBarrier specifically works.
Who can participate?
Patients aged 18-65 who have had type 2 diabetes for at least 1 year.
What does the study involve?
If you are interested in this study we will invite you for a screening visit. If you decide to participate you will be asked to sign an informed consent form. Your doctor will then perform some tests and procedures to determine whether you are eligible for the study. If you are eligible for the study you will be randomly allocated to either receive the EndoBarrier device for 12 months and subsequently a diet for a further 12 months, or you will receive standard medical therapy and a diet for 24 months. All patients will receive specialist support from a doctor specialising in the treatment of diabetes and a dietitian. On some of the study visits, we will also ask you to participate in specific tests which will help us to assess your metabolism, brain activity, insulin sensitivity and food preference. Participation in these tests is entirely optional. More information about these tests can be found in the patient information sheet.
What are the possible benefits and risks of participating?
The direct benefit of taking part in this study will be a possible improvement in your blood glucose and HbA1c, blood pressure, weight loss and reduction in long-term health risks, particularly cardiovascular diseases. The risks associated with the EndoBarrier procedure include the same risks observed with other upper gastrointestinal endoscopic procedures. The EndoBarrier device has been safely used in several clinical trials and in more than 300 subjects with both obesity and type 2 diabetes.
Where is the study run from?
Study visits will either be performed at Imperial College London (St. Mary’s Hospital or Hammersmith Hospital in London) or University Hospital Southampton (Southampton General Hospital).
When is the study starting and how long is it expected to run for?
The study will run from November 2014 to November 2018.
Who is funding the study?
NIHR Efficacy and Mechanisms Evaluation (UK).
Who is the main contact?
Natalia Klimowska-Nassar
n.klimowska@imperial.ac.uk
Contact information
Public
Imperial Clinical Trials Unit
Stadium House
68 Wood Lane
London
W12 7RH
United Kingdom
 ORCID ID |
0000-0003-3655-7436 |
|---|---|
| Phone | +44 (0)7764 146 156 |
| n.klimowska@imperial.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | A randomised controlled trial of a duodenal sleeve bypass device (EndoBarrier) compared with standard medical therapy for the management of obese subjects with type 2 diabetes |
| Study hypothesis | 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. In summary, we hypothesise that this study reduces weight by decreasing hunger, increasing fullness, changing food preference and reducing food reward in obese people with type 2 diabetes. We further hypothesise that the Endobarrier improves glycaemic control with an HbA1C reduced by 20%. |
| Ethics approval(s) | NRES Committee London – Fulham, 07/07/2014, ref: 14/LO/0871 |
| Condition | Topic: Diabetes; Subtopic: Type 2; Disease: Device studies, Diabetic Control, Hypoglycemia, Metabolic, Nutrition, Obesity |
| Intervention | EndoBarrier or Standard Medical Therapy: Subject will be either having the EndoBarrier device or standard medical therapy (medication, diet and exercise) treatment for 12 months followed by another 12 months follow-up period. In an attempt to avoid surgery a new device and concept has been developed called a duodenal-jejunal sleeve bypass. The duodenal-jejunal bypass sleeve device (EndoBarrier GI Dynamics Inc, Lexington MA) consists of a single use endoscopic implant in the small bowel and is 60 cm. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | HbA1c; Timepoint(s): 12 months |
| Secondary outcome measures | 1. Cost-effectiveness of the EndoBarrier device; Timepoint(s): 24 months; 2. HbA1c, Blood pressure, weight loss; Timepoint(s): 12 months 3. Long-term cost-effectiveness of the EndoBarrier device; Timepoint(s): 24 months 4. Mechanism of effect; Timepoint(s): 12 months 5. Safety of the EndoBarrier and frequency of adverse events; Timepoint(s): 24 months |
| Overall study start date | 01/11/2014 |
| Overall study end date | 04/01/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 160; UK Sample Size: 160 |
| Total final enrolment | 170 |
| Participant inclusion criteria | 1. Age 18-65 years (male or female) 2. T2DM for at least 1 year (HbA1c 7.5-10.0% = 58-86 mmol/mol) 3. On oral T2DM medications (metformin is allowed, but not required) 4. BMI 30-50 kg/m2 with adequate insulin reserve as indicated with insulin C-peptide levels > 0.5 ng/mL |
| Participant exclusion criteria | 1. Language barrier, mental incapacity, unwillingness or inability to understand and be able to complete questionnaires 2. Non-compliance with eligibility criteria 3. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods 4. Current use of insulin 5. Previous diagnosis with Type 1 DM or a history of ketoacidosis 6. Requirement of NSAIDs (non-steroidal anti-inflammatory drugs) or prescription of anticoagulation therapy during the implant period 7. History of iron deficiency and/or iron deficiency anaemia 8. Symptomatic gallstones or kidney stones at the time of screening 9. History of coagulopathy, upper gastro-intestinal bleeding conditions such as oesophageal or gastric varices, congenital or acquired intestinal telangiectasia 10. Previous GI surgery that could affect the ability to place the device or the function of the implant 11. Presence of active H. pylori using C13 urea breath test (if subjects have active H. pylori at baseline, they can receive appropriate treatment and then subsequently enrol into the study) 12. Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder 13. 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 14. Severe depression, unstable emotional or psychological characteristics (indicated by Beck Depression Inventory II score >28) 15. Poor dentition and inability to adequately chew food 16. Planned holidays up to three months following the EndoBarrier Implant 17. Previous EndoBarrier implantation 18. Metal implant unsuitable for MRI scanning and claustrophobia as contraindications for MRI scans (sub-group 1 - fMRI study only) 19. Vegetarian, vegan, gluten or lactose intolerance as unsuitable for fMRI food picture paradigm (sub-group 1 fMRI only) |
| Recruitment start date | 01/12/2014 |
| Recruitment end date | 01/12/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
W2 1LA
United Kingdom
Southampton
SO16 6YD
United Kingdom
Sponsor information
University/education
c/o Christine Buicke
Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
England
United Kingdom
| c.buicke@imperial.ac.uk | |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 05/05/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/11/2017 | 25/07/2019 | Yes | No |
| Other publications | report | 14/11/2019 | 26/02/2021 | Yes | No |
| Results article | results | 01/11/2020 | 26/02/2021 | Yes | No |
| Results article | 14/06/2021 | 15/10/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
15/10/2021: Publication reference added.
26/02/2021: Publication references added.
20/01/2021: Total final enrolment added.
19/01/2021: Contact details updated.
05/11/2019: The following changes have been made:
1. The overall trial end date has been changed from 30/11/2018 to 04/01/2019.
2. An intention to publish date has been added.
25/07/2019: ClinicalTrials.gov number and publication reference added.
