EndoBarrier Versus Intragastric Balloon in Obese Diabetic Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Sponsor:
Information provided by (Responsible Party):
Anna Casu, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
ClinicalTrials.gov Identifier:
NCT01848795
First received: May 3, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted

May 3, 2013
May 3, 2013
May 2013
May 2017   (final data collection date for primary outcome measure)
Glycated hemoglobin [ Time Frame: 12 months ] [ Designated as safety issue: No ]
measurement of diabetes metabolic control
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
EndoBarrier Versus Intragastric Balloon in Obese Diabetic Patients
Study of Metabolic Effects of EndoBarrier Versus Intragastric Balloon in Obese Patients With Type 2 Diabetes.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Obesity
  • Device: EndoBarrier Gastrointestinal Liner
    Endoscopy placement of EndoBarrier, and clinical and biochemical follow up
    Other Name: produced by GI Dynamics
  • Device: BioEnterics Intragastric Balloon System
    Endoscopy placement of EndoBarrier, and clinical and biochemical follow up
  • Experimental: EndoBarrier Gastrointestinal Liner
    The treatment in this arm is the endoscopic positioning of the EndoBarrier Gastrointestinal Liner and follow up.
    Intervention: Device: EndoBarrier Gastrointestinal Liner
  • Active Comparator: Intragastric Balloon
    The treatment in this arm is the endoscopic positioning of the Intragastric Balloon System as a comparator and follow up.
    Intervention: Device: BioEnterics Intragastric Balloon System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
May 2017
May 2017   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Anna Casu, MD +390912192111 acasu@ismett.edu
Contact: Mario Traina, MD +390912192111 mtraina@ismett.edu
Italy
 
NCT01848795
IRRB/30/10
No
Anna Casu, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Not Provided
Principal Investigator: Anna Casu, MD The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP