A Phase 4 interventional study of EndoBarrier Gastrointestinal Liner and Easy life balloon in Type 2 Diabetes and Obesity, sponsored by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-03-24.
Sponsored by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies · Phase 4, Interventional, and Treatment
Obese patients with Type 2 diabetes (T2D) have a 80-98% chance of having their disease cured or improved following bariatric surgery. This could be explained by weight loss or by changes of nutrient absorption or gut hormone secretion. The comparison of glucose metabolism in patients undergoing malabsorptive or mechanical procedures will clarify this matter. EndoBarrier is an endoscopically delivered device that mimics malabsorptive surgical procedures while the endoscopically placed intragastric balloon induces weight loss with a mechanical action.
The present study hypothesis is that the bypass of the first portion of the intestine obtained with the EndoBarrier will be more effective in improving glucose metabolism than the reduction of food intake obtained with the intragastric balloon. Since similar weight loss is expected in the two groups, the study will aid in understanding the mechanisms behind the metabolic improvement seeing after intestine bypass.
Bariatric surgery is an effective therapy for obesity. Malabsorption-based surgical techniques (excluding the first part of the gastrointestinal tract from the alimentary circuit) are also effective in correcting T2D, even before any significant weight loss has occurred. Proposed mechanisms to explain this beneficial effect include caloric restriction, altered secretion of gut hormones due to duodenal exclusion or due to contact of undigested food with the jejunal mucosa, pancreatic islet hyperfunction, changes of intestinal flora, mucosal inflammation, and/or changes in the biliary acid re-circulation.
EndoBarrier is an endoscopically delivered device that mimics malabsorptive surgical procedures while the endoscopically placed intragastric balloon induces weight loss with a mechanical action.
The present study is a prospective, randomized clinical trial. It will compare the metabolic compensation between patient treated with EndoBarrier and patient treated with Intragastric Balloon.
The aims will be: comparison of glycemic control as measured by hemoglobin A1c (HbA1c), change in oral hypoglycemic drug consumption and body loss from baseline and during follow up in the two groups; evaluation of mechanisms implicated in glycemic control by measuring basal and stimulated insular hormones, glucose levels and gastrointestinal hormones; creation of a bio-bank and dedicated database to collect biological samples for further future studies.
Obese adult T2D patients (BMI ≥ 30) with diabetes duration \<10 years will be randomized to receive either EndoBarrier (n=45) or Intragastric Balloon (n=45). The devices will be implanted and kept in place for the first 12 months of study and then removed. Clinical and biochemical data will be collected every 3 months during the 12 months of implant and for the subsequent 12 months after removal.
Statistics describing variables at baseline, at subsequent visits and at the end of the study will be produced for both groups of patients. The Student's t-test will be used for a cross-sectional analysis while the mixed model system will be used for longitudinal observations. Multivariate analysis will also be applied to better characterize differences that may be seen between the two groups.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 90 is above the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →The Mediterranean Institute for Transplantation and Advanced Specialized Therapies is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
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The treatment in this arm is the endoscopic positioning of the EndoBarrier Gastrointestinal Liner and follow up.
Device: EndoBarrier Gastrointestinal Liner
The treatment in this arm is the endoscopic positioning of the intragastric balloon (Easy life balloon) as a comparator and follow up.
Device: Easy life balloon
Endoscopy placement of EndoBarrier, and clinical and biochemical follow up
Also known as: produced by GI Dynamics
Endoscopy placement of EndoBarrier, and clinical and biochemical follow up
Glycated hemoglobin
measurement of diabetes metabolic control
Time frame: 12 months
This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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The Mediterranean Institute for Transplantation and Advanced Specialized Therapies