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EndoBarrier Versus Intragastric Balloon in Obese Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01848795
Recruitment Status : Recruiting
First Posted : May 8, 2013
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Obesity Device: EndoBarrier Gastrointestinal Liner Device: Easy life balloon Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Metabolic Effects of EndoBarrier Versus Intragastric Balloon in Obese Patients With Type 2 Diabetes.
Study Start Date : May 2013
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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


Outcome Measures

Primary Outcome Measures :
  1. Glycated hemoglobin [ Time Frame: 12 months ]
    measurement of diabetes metabolic control


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848795


Contacts
Contact: Anna Casu, MD +390912192111 acasu@ismett.edu
Contact: Mario Traina, MD +390912192111 mtraina@ismett.edu

Locations
Italy
ISMETT Recruiting
Palermo, Italy, 90127
Contact: Anna Casu, MD    +390912192111    acasu@ismett.edu   
Contact: Mario Traina, MD    +390912192111    mtraina@ismett.edu   
Principal Investigator: Anna Casu, MD         
Sub-Investigator: Mario Traina, MD         
Sponsors and Collaborators
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Investigators
Principal Investigator: Anna Casu, MD The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
More Information

Responsible Party: Anna Casu, Diabetology Attending, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
ClinicalTrials.gov Identifier: NCT01848795     History of Changes
Other Study ID Numbers: IRRB/30/10
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015

Keywords provided by Anna Casu, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies:
Type 2 Diabetes
Obesity
gastrointestinal hormones
intestinal bypass
endoscopy

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases