Clinical trial NCT01848795: EndoBarrier Versus Intragastric Balloon in Obese Diabetic Patients
Official title: Study of Metabolic Effects of EndoBarrier Versus Intragastric Balloon in Obese Patients With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Obesity
Keywords: Type 2 Diabetes
Obesity
gastrointestinal hormones
intestinal bypass
endoscopy
Lead sponsor: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adults (18-60 year old)
* Type 2 Diabetes diagnosed less than 10 years ago
* Obesity (BMI \> 30)

Exclusion Criteria:

* pregnancy
* inflammatory bowel disease
* peptic ulcer
* gastrointestinal disease preventing device positioning
* pancreatitis,
* coronary artery disease
* symptomatic pulmonary disease
* infection at the time of device placement,
* high risk of gastrointestinal bleeding (coagulopathy, bleeding diathesis, anti-coagulant therapy, Non-Steroid Anti-Inflammatory Drugs)
* altered GI anatomy that could affect device placement
* contraindication of positioning of the devices as per technical description of the producer
* C-peptide negative diabetes
* failure to understand the study protocol or not willing to undergo planned follow-up

Primary outcomes:
measure: Glycated hemoglobin
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: ISMETT
Study officials:
affiliation: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
name: Anna Casu, MD
role: PRINCIPAL_INVESTIGATOR
References: