Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese (ENDO)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GI Dynamics
ClinicalTrials.gov Identifier:
NCT01728116
First received: November 13, 2012
Last updated: March 6, 2015
Last verified: October 2014
  Purpose

To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes


Condition Intervention
Type 2 Diabetes in Obese Subjects
Device: EndoBarrier
Procedure: Sham Procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents

Resource links provided by NLM:


Further study details as provided by GI Dynamics:

Primary Outcome Measures:
  • Improvement in HbA1c [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight Loss [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Improvements in select cardiovascular risk factors, such as cholesterol [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device (EndoBarrier)
Device for glycemic control
Device: EndoBarrier
Sham Comparator: Sham Procedure
sham procedure
Procedure: Sham Procedure

Detailed Description:

This is a randomized, double blinded, prospective study. Subjects will be evaluated and randomized to a treatment group if they qualify for the study. Subjects will receive either a device or sham procedure. Throughout the study glycemic control and various laboratory tests will be evaluated. A comparison of glycemic control between the two groups will be assessed as the primary outcome measurement.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HbA1c ≥ 7.5% and ≤ 10%
  • BMI ≥ 30 and ≤ 55

Exclusion Criteria:

  • Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
  • C-peptide < 1.0 ng/mL
  • Previous GI surgery or abnormal GI anatomical finding
  • Prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728116

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, Arkansas
Little Rock Diagnostic Center (LRDC)
Little Rock, Arkansas, United States, 72205
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Colorado
University of Colorado/ Anschutz Health & Wellness Center
Aurora, Colorado, United States, 80045
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60208
United States, Kentucky
Kentucky Research Group
Louisville, Kentucky, United States, 40218
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112-2699
United States, Maryland
MedStar Health Research Institute
Hyattsville, Maryland, United States, 20782
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
St Louis, Missouri, United States, 63110
United States, Montana
Billings Clinic
Billings, Montana, United States, 59101
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Legacy Research Institute
Portland, Oregon, United States, 97232
United States, Tennessee
Endocrinology Consultants of East Tennessee & Gastrointestinal Associates
Knoxville, Tennessee, United States, 37909
United States, Texas
Dallas Diabetes
Dallas, Texas, United States, 75230
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-7170
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Sponsors and Collaborators
GI Dynamics
Investigators
Study Chair: Lee M Kaplan, MD, PhD Massachusetts General Hospital
Study Director: Keith Gersin, MD Carolinas Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: GI Dynamics
ClinicalTrials.gov Identifier: NCT01728116     History of Changes
Other Study ID Numbers: 09-1
Study First Received: November 13, 2012
Last Updated: March 6, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by GI Dynamics:
glycemic control, type 2 diabetes, device, obese

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

ClinicalTrials.gov processed this record on May 29, 2015