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 June 2014 by GI Dynamics
Sponsor:
Information provided by (Responsible Party):
GI Dynamics
ClinicalTrials.gov Identifier:
NCT01728116
First received: November 13, 2012
Last updated: September 3, 2014
Last verified: June 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 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

Contacts
Contact: Kelly Woessner kwoessner@gidynamics.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Kentress Davison    205-934-4112    kdavison@uab.edu   
Principal Investigator: Fernando Ovalle, MD         
Principal Investigator: Shajan Sugandha, MD         
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    karentilley@lrdc.com   
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    Denice.Dubuclet@cshs.org   
Contact: Laura Sarmiento    310-423-4295    Laura.Sarmiento@cshs.org   
Principal Investigator: Ruchi Mathur, MD         
Principal Investigator: Miguel Burch, MD         
United States, Colorado
University of Colorado/ Anschutz Health & Wellness Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Jeanne Anne Breen    303-724-9015    jeanneanne.breen@ucdenver.edu   
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    garobal@emory.edu   
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       d-harakal@northwestern.edu   
Principal Investigator: Lisa Neff, MD         
Principal Investigator: John Martin, MD         
United States, Louisiana
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112-2699
Contact: Cynthia Moreau    504-988-1842    cmoreau@tulane.edu   
Contact: Vivian Fonseca, MD    504-988-4026    vfonseca@tulane.edu   
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    vanita.aroda@medstar.net   
Principal Investigator: Vanita Aroda, MD         
Principal Investigator: Timothy Koch, MD         
United States, Massachusetts
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         
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Waheed Khan    617-638-5907    Waheed.Khan@bmc.org   
Principal Investigator: Caroline Apovian, MD         
Principal Investigator: Donald Hess, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Lori Kempf       kempfl@med.umich.edu   
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    radaket@wusm.wustl.edu   
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    mlindell@billingsclinic.org   
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    kmantha@chpnet.org   
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    mduclos@med.unc.edu   
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    mocanua@ccf.org   
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    areiter@lhs.org   
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    gmcdonald@endoconsultants.com   
Contact: Kathy Karnes    865-558-0687    kkarnes@gihealthcare.com   
Principal Investigator: William Law, Jr., MD         
Principal Investigator: Bergein Overholt, MD         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-7170
Contact: Laura Golici    214-648-2515    Laura.golici@utsouthwestern.edu   
Principal Investigator: Ildiko Lingvay, MD         
Principal Investigator: Deepak Agrawal, MD         
Dallas Diabetes Recruiting
Dallas, Texas, United States, 75230
Contact: Marta Diaz    972-566-5678    recruit@dallasdiabetes.com   
Principal Investigator: Julio Rosenstock, MD         
Principal Investigator: Gerald Isbell, MD         
The Methodist Hospital Research Institute Recruiting
Houston, Texas, United States, 77030
Contact: Darrel Cleere    713-441-6232    DWCLEERE@houstonmethodist.org   
Principal Investigator: Abhishek Kansara, MD         
Principal Investigator: Nabil Tariq, MD         
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: September 3, 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
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014