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EndoBarrier Versus Intragastric Balloon in Obese Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01848795
Recruitment Status : Unknown
Verified March 2015 by Anna Casu, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies.
Recruitment status was:  Recruiting
First Posted : May 8, 2013
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Anna Casu, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Tracking Information
First Submitted Date  ICMJE May 3, 2013
First Posted Date  ICMJE May 8, 2013
Last Update Posted Date March 24, 2015
Study Start Date  ICMJE May 2013
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
Glycated hemoglobin [ Time Frame: 12 months ]
measurement of diabetes metabolic control
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01848795 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EndoBarrier Versus Intragastric Balloon in Obese Diabetic Patients
Official Title  ICMJE Study of Metabolic Effects of EndoBarrier Versus Intragastric Balloon in Obese Patients With Type 2 Diabetes.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes
  • Obesity
Intervention  ICMJE
  • Device: EndoBarrier Gastrointestinal Liner
    Endoscopy placement of EndoBarrier, and clinical and biochemical follow up
    Other Name: produced by GI Dynamics
  • Device: Easy life balloon
    Endoscopy placement of EndoBarrier, and clinical and biochemical follow up
Study Arms  ICMJE
  • 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 (Easy life balloon) as a comparator and follow up.
    Intervention: Device: Easy life balloon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 3, 2013)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01848795
Other Study ID Numbers  ICMJE IRRB/30/10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anna Casu, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Study Sponsor  ICMJE The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anna Casu, MD The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
PRS Account The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Verification Date March 2015

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