EndoBarrier Versus Intragastric Balloon in Obese Diabetic Patients

March 23, 2015 updated by: Anna Casu, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy, 90127
        • Recruiting
        • ISMETT
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anna Casu, MD
        • Sub-Investigator:
          • Mario Traina, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EndoBarrier Gastrointestinal Liner
The treatment in this arm is the endoscopic positioning of the EndoBarrier Gastrointestinal Liner and follow up.
Device: EndoBarrier Gastrointestinal Liner
Endoscopy placement of EndoBarrier, and clinical and biochemical follow up
Other Names:
  • produced by GI Dynamics
Active Comparator: Intragastric Balloon
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin
Time Frame: 12 months
measurement of diabetes metabolic control
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Investigators

  • Principal Investigator: Anna Casu, MD, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

May 3, 2013

First Posted (Estimate)

May 8, 2013

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 23, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRRB/30/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on EndoBarrier Gastrointestinal Liner

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe