Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by GI Dynamics
Information provided by (Responsible Party):
GI Dynamics Identifier:
First received: November 13, 2012
Last updated: December 18, 2014
Last verified: October 2014

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

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.


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

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 identifier: NCT01728116

Contact: Kelly Woessner

  Hide Study Locations
United States, Alabama
University of Alabama at Birmingham Active, not recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
Mayo Clinic Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Martha Thomas, RN    480-301-6726      
Principal Investigator: John DiBaise, MD         
Principal Investigator: Lori Roust, MD         
United States, Arkansas
Little Rock Diagnostic Center (LRDC) Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Karen Tilley    501-221-5889   
Principal Investigator: Shunzhon Bao, MD         
Principal Investigator: Angelo Coppola, MD         
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Denice Dubuclet, DC    310-423-6996   
Contact: Laura Sarmiento    310-423-4295   
Principal Investigator: Ruchi Mathur, MD         
Principal Investigator: Miguel Burch, MD         
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Elizabeth Colbert    650-723-3186   
Principal Investigator: Tracey McLaughlin, MD         
Principal Investigator: John Morton, MD         
United States, Colorado
University of Colorado/ Anschutz Health & Wellness Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Jeanne Anne Breen    303-724-9015   
Contact: Holly Wyatt, MD         
Principal Investigator: Holly Wyatt, MD         
Principal Investigator: Gregory Austin, MD, MPH         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30303
Contact: Gonzalo Robalino, MD    404-616-3719   
Principal Investigator: Guillermo Umpierrez, MD         
Principal Investigator: Temitope Foster, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60208
Contact: Donna Harakal, RN,CCRC   
Principal Investigator: Lisa Neff, MD         
Principal Investigator: Rajesh Keswani, MD         
United States, Kentucky
Kentucky Research Group Recruiting
Louisville, Kentucky, United States, 40218
Contact: Jackie Bourke, RN, CCRC   
Principal Investigator: David Winslow, MD         
Principal Investigator: Paul Brown, MD         
United States, Louisiana
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112-2699
Contact: Cynthia Moreau    504-988-1842   
Contact: Vivian Fonseca, MD    504-988-4026   
Principal Investigator: Vivian A. Fonseca, MD         
Principal Investigator: Sanjay Sikka, MD         
United States, Maryland
MedStar Health Research Institute Recruiting
Hyattsville, Maryland, United States, 20782
Contact: Vanita Aroda, MD    301-560-2950   
Principal Investigator: Vanita Aroda, MD         
Principal Investigator: Timothy Koch, MD         
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Waheed Khan    617-638-5907   
Principal Investigator: Caroline Apovian, MD         
Principal Investigator: Donald Hess, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Laurie Bissett    617-726-1687    LBISSETT@PARTNERS.ORG   
Principal Investigator: Enrico Cagliero, MD         
Principal Investigator: William Brugge, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Rita Hench   
Principal Investigator: Elif Oral, MD         
Principal Investigator: Grace Elta, MD         
United States, Minnesota
Mayo Clinic Minnesota Recruiting
Rochester, Minnesota, United States, 55905
Contact: Adrian Vella, MD    507-284-3754      
Principal Investigator: Adrian Vella, MD         
Principal Investigator: Barham Abu Dayyeh, MD         
United States, Missouri
Washington University Recruiting
St Louis, Missouri, United States, 63110
Contact: Terri Radake    314-747-5366   
Principal Investigator: Dominic Reeds, MD         
Principal Investigator: Steven Edmundowicz, MD         
United States, Montana
Billings Clinic Recruiting
Billings, Montana, United States, 59101
Contact: Marilyn Lindell    406-657-4111   
Principal Investigator: James Mack, MD         
Principal Investigator: Bret Murray, MD         
United States, New York
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Kamala Mantha    212-420-3569   
Principal Investigator: David Carr-Locke, MD         
Principal Investigator: Aida Saliby, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Michelle Duclos    919-957-5678   
Principal Investigator: Laura Young, MD         
Principal Investigator: Nicholas Shaheen, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Andreea Mocanu    216-444-9612   
Principal Investigator: Laurence Kennedy, MD         
Principal Investigator: Stacy Brethauer, MD         
United States, Oregon
Legacy Research Institute Recruiting
Portland, Oregon, United States, 97232
Contact: Amy Reiter    503-413-7094   
Principal Investigator: Richard Bergstrom, MD         
Principal Investigator: Kevin Reavis, MD         
United States, Tennessee
Endocrinology Consultants of East Tennessee & Gastrointestinal Associates Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Gale McDonald    865-342-4631   
Contact: Kathy Karnes    865-558-0687   
Principal Investigator: William Law, Jr., MD         
Principal Investigator: Bergein Overholt, MD         
United States, Texas
Dallas Diabetes Recruiting
Dallas, Texas, United States, 75230
Contact: Marta Diaz    972-566-5678   
Principal Investigator: Julio Rosenstock, MD         
Principal Investigator: Gerald Isbell, MD         
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-7170
Contact: Laura Golici    214-648-2515   
Principal Investigator: Ildiko Lingvay, MD         
Principal Investigator: Deepak Agrawal, MD         
The Methodist Hospital Research Institute Recruiting
Houston, Texas, United States, 77030
Contact: Darrel Cleere    713-441-6232   
Principal Investigator: Abhishek Kansara, MD         
Principal Investigator: Nabil Tariq, MD         
Sponsors and Collaborators
GI Dynamics
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 Identifier: NCT01728116     History of Changes
Other Study ID Numbers: 09-1
Study First Received: November 13, 2012
Last Updated: December 18, 2014
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 processed this record on March 03, 2015