EndoBarrier TM Gastrointestinal Liner Diabetes Trial (EndoBarrier)

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

National Institute for Health Research, United Kingdom, University Hospital Southampton NHS Foundation Trust, Brunel University, University of Surrey

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.

Patients will be recruited via primary care and secondary care trusts. After an initial screening visit to determine subject's eligibility, they will be randomised to either the EndoBarrier or Control arm (conventional medical therapy including dietary counselling), and invited for 15 study visits over 24 months. The standard medical therapy drug titrations 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 of this trial are published following study completion. Patients will receive the intervention for 12 months and then be followed up for 12 months. They will be contacted via telephone in between visits to monitor any problems and boost motivation. The main outcome of this study is to compare the EndoBarrier device with conventional medical therapy, diet and exercise for obesity related type 2 diabetes and their effectiveness on: Metabolic state as defined by the International Diabetes Federation (IDF) with an HbA1c < 6% (or < 42 mmol/mol) and a blood pressure < 135/85mmHg Absolute weight loss. Patients will also be invited to participate in one of 3 sub-groups as part of the mechanistic studies (Group 1: functional MRI (fMRI), Group 2: insulin clamps or Group 3: food preference). Participation in the sub-studies is optional. The following assessments will be performed at visit 1 (Screening Visit): Informed consent, inclusion and exclusion criteria, demographics, medical history, physical examination, body measurements including height, weight and waist , vital signs, ECG, urine albumin-creatinine ratio, routine haematology and biochemistry, C13 urea breath test and urine pregnancy test, if applicable. Additional checks will be completed if the subject consents to take part in a sub-group mechanistic study. Once all data including blood test results related to the screening have been obtained, the Investigator will review the subject's eligibility to continue in the trial. If the subject is eligible after this review, the subject will be randomised into one of the two study arms (EndoBarrier or Control). Both groups will undergo the following measurements: Body weight and waist circumference, blood pressure, changes in illness and medication and adverse events will be checked at all visits. Blood samples will be obtained at 13 visits Urine albumin:creatinine ratio: urine samples will be collected at visit 3, 5, 8, 10 and 14 Questionnaires (Health Economics) will be completed at visits 3, 5, 6, 7, 8, 10 and 14. Dietary counselling: at visits 2, 4 (control arm only), 6, 7, 9, 11, 12, 13, and 15 subjects will receive diet (either in groups or individually) by a qualified dietitian. EndoBarrier group: Visit 2 (- 4 weeks) will include dietary counselling with a dietitian, dietary preparation pre- and post-intervention and a medical consultation (including distribution of proton pump inhibitors) in preparation for the EndoBarrier implant. At visit 4 (0 weeks) the EndoBarrier device will be implanted. The subject will attended the hospital in a fasting state and will receive a general anaesthetic before the device placement procedure. A small tube (the endoscope) is inserted into the mouth and guided to the small intestine for visual examination of this area by the physician. Then a guide wire will be inserted through the endoscope, after which the endoscope is removed but the guide wire is left in place. A capsule (containing the device) is placed on the guide wire and guided to the destination in the small intestine. The physician can see the capsule under x-rays as it is moved towards the small intestine. When the physician determines that the capsule has reached the correct location, the guide wire is removed, which releases the device. When the device is released, it also releases a small plastic ball (slightly larger than a pea). The ball is excreted naturally via a stool. Normally, this does not cause any discomfort. The device remains in the small intestine until it is removed after 12 months. After the procedure (up to 12 hours) the subject may need to stay overnight in the hospital so the physician can monitor their condition, but this usually is not required. During insertion fluroscopy will be used to determine the position of the device. Videos and photos of the fluoroscopy images are recorded to help the investigators make treatment decisions and may be passed on to the study sponsor. The images will not contain any patient identifiable data but will be labelled with initials and study participation number only. At visit 11 (12 months) the EndoBarrier device will be removed. The removal procedure is comparable to the placement procedure but usually requires less time. Before the device removal procedure, the subject will receive a general anaesthetic. During device removal, an endoscope is inserted into the mouth and guided to the small intestine for visual examination of this area by the physician. A guide wire is inserted into the endoscope. The end of the endoscope has a small hook, which the physician will use to pull the device back into the endoscope. The endoscope containing the device is then removed through the mouth. The physician will then insert the endoscope again to inspect the area where the device was placed. After the procedure, the subject can return home. All subjects in the EndoBarrier arm will see a gastroenterologist or equivalent specialist at study visit 2, 6, 7, 9, 11, 12, 13 and 15 to discuss their well-being and any questions regarding their EndoBarrier implant. EndoBarrier patients will also receive frequent reviews with a diabetes specialist to review their medication regimen (visits 2, 6, 7, 9, 12, 13 and 15). Control group (Standard Medical Therapy) Standard medical therapy will be carried out in accordance with the guidelines of the American Diabetes Association. Patients will be seen at visits 2, 4, 6, 7, 9, 11, 12, 13 and 15 for follow-up of their diabetes control by a diabetes specialist. Both groups will provide a blood sample for DNA/RNA sampling: at visit 3 and samples for metabolomics (blood, urine, feces): at visits 3, 5, 8, 10 and 14 Subjects who agree to participate in a sub-study will be asked to complete additional tests including: Fasting Gut hormones and metabolites (Group 1-3): at visits 3, 5, 8, 10 and 14 Post meal gut hormones and metabolites (Group 1 and 3): at visits 3, 5, 8, 10 Eating and behaviour questionnaires (Group 1-3): at visits 3, 8, 10 and 14 Functional MRI (Group 1): at visits 3 and 8 Taste and Food preference (Group 3): at visits 3, 5, and 8 Eating behaviour computerised tasks (Group 1 and 3): at visits 3, 8, 10 and 14 Cognitive Assessment tasks (Group 1): at visits 3, 8 and 10 Insulin Clamps (Group 2): at visits 3, 5, and 8

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

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.

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.

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.

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.

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%.

To investigate the mechanism of the effect of the EndoBarrier, venous blood samples will be taken at intervals by venepuncture through a cannula placed in the antecubital fossa. Serial plasma levels of glucose and other metabolites, bile acids, glucose, insulin, leptin, gut hormones (including ghrelin, GLP-1, PYY), adipocytokines and markers of insulin resistance, and inflammation will be measured. Assays will be performed by the Dept. of Chemical Pathology at Imperial College Healthcare NHS Trust and by in-house assays, outside contracts and commercial kits for radio-immunoassay and ELISA. These will be measured in the fasted and/or postprandial state for each patient and compared within and between the groups using parametric/non-parametric repeated measures statistical testing. Regressions will be performed with clinical outcomes (i.e. BMI, glucose control) to identify predictive markers and generate mechanistic hypotheses.

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

To investigate the mechanism of the effect of the EndoBarrier, plasma, urine and faecal samples for metabolomics will be collected at visit 3, 5, 8 and 10 and 14. All samples will be analysed using Mass spectroscopy and NMR spectroscopy. Metabolic datasets will be analysed using principal component analysis (PCA) and orthogonal partial least-squares analysis (O-PLS). The metabolic and microbial data will also be analysed in relation to response measurements such as BMI, gut hormone levels and etc. using O-PLS regression analysis and Bayesian approaches. A range of statistical methods will be optimised and applied to the data to identify weight loss and T2DM-associated microbiota and metabolites.

Changes in brain reward systems before and after the EndoBarrier device to investigate the mechanism of the effect of the EndoBarrier.

Patients will have fMRI scans to examine between brain function related to food reward and addictive behaviours at baseline and early after intervention, and these will be correlated to psychological questionnaires, computerised tasks, and test meals. Comparison of brain activation during fMRI paradigms and outcomes from behavioural measures of food hedonics and questionnaires will be compared between groups using a 2x2 ANOVA design including group (control vs. Endobarrier) between subject factor, time (baseline vs. follow-up visit) within subject factor, and group x time interaction to identify differential effects between groups. In addition linear regression will be performed to measure the correlation of variables at baseline or during the intervention with primary outcomes at 1 year e.g. weight loss and decreases in HbA1c within each group.

Changes in body fat content before and after the EndoBarrier device to investigate the mechanism of the effect of the EndoBarrier.

As well as baseline anthropometric measurements of height, weight, waist and hip circumference, patients will also have their percentage body fat determined by bio-electrical impedance analysis. This is a painless, safe procedure to measure total body fat involves lying on a bed, having two sticky pads placed on a hand and foot, and lying still for 1 minute, or standing on a metal platform for 1 minute so that the body's electrical resistance can be measured.

Changes in food preference before and after the EndoBarrier device to investigate the mechanism of the effect of the EndoBarrier.

Sweet taste detection testing: 7 ascending sucrose concentrations in solution will used to determine sweet detection thresholds. The subjects will sample the stimulus in the mouth and then spit the sample in a container to then indicate whether the stimulus was water or not. Consummatory taste reward: 5 ascending fat and sucrose solutions/ice-cream will be used to test responses in intensity ratings and hedonic reward. Participants will be asked to put the solutions into their mouths and then to spit it out into a bucket. While the solution is in the participants' mouths they will be asked to rate its intensity and pleasantness using visual analogue scales. Analysis: Sweet taste detection thresholds and visual analogue taste ratings will be quantified for each patient and compared within and between the groups at 3 time points using parametric/non-parametric repeated measures statistical testing.

To investigate the mechanism of the effect of the EndoBarrier, blood (15 ml) will be taken to extract DNA and RNA for examination of genetic markers which predict weight loss, genetic abnormalities causing or contributing to obesity and insulin resistance (including array comparative genomic hybridization for copy number variations, epigenetic analysis, whole genome or exome sequencing, DNA sequencing of candidate genes (such as MC4R, POMC, leptin receptor, SIM1); and polymorphisms or mutations associated with obesity, diabetes mellitus, PCOS, fat distribution and body composition (using PCR based SNP analysis)56-58. RNA will be extracted from blood to perform genome-wide expression analysis.

Changes in hepatic or peripheral insulin sensitivity before and after the EndoBarrier device to investigate the mechanism of the effect of the EndoBarrier

Patients will undergo a euglycaemic hyperinsulinaemic clamp with stable isotope infusion to determine overall insulin and compartment-specific insulin sensitivity (liver, muscle and adipose depot). Blood samples will be taken every 5 minutes to measure blood glucose concentration and the dextrose infusion will be adjusted accordingly. Overall and tissue specific insulin sensitivity will be quantified for each patient and compared within and between the groups at 3 time points using parametric/non-parametric repeated measures statistical testing. Regressions will be performed with clinical outcomes (i.e. BMI, glucose control) to identify predictive markers and generate mechanistic hypotheses.

To estimate the cost-effectiveness of the EndoBarrier device compared with conventional treatment over the trial period using Quality of Life questionnaires. These comprise the EQ-5D-5L questionnaire to assess health-related quality of life, and a bespoke questionnaire designed to collect information about patients' use of health and social care resources (for costing purposes). The resource use questionnaire has been adapted from existing instruments and will ask patients to specify what services they have used since the previous assessment.

Inclusion Criteria: 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 Exclusion Criteria: 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 Planned holidays up to three months following the EndoBarrier Implant Previous EndoBarrier implantation Metal implant unsuitable for MRI scanning and claustrophobia as contraindications for MRI scans (sub-group 1 - fMRI study only) Vegetarian, vegan, gluten or lactose intolerance as unsuitable for fMRI food picture paradigm (sub-group 1 - fMRI only)

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