Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese (ENDO)
This study is currently recruiting participants.
Verified May 2013 by GI Dynamics
Sponsor:
GI Dynamics
Information provided by (Responsible Party):
GI Dynamics
ClinicalTrials.gov Identifier:
NCT01728116
First received: November 13, 2012
Last updated: May 31, 2013
Last verified: May 2013
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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 Metformin and/or Sulfonylurea 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 ≥ 8.0% and ≤ 10%
- BMI ≥ 30 and ≤ 50
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728116
Contacts
| Contact: Jennifer L Cormier | jcormier@gidynamics.com |
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Kentress Davison 205-934-4112 kdavison@uab.edu | |
| Contact: Susan Ferguson 205-934-4112 susanf@uab.edu | |
| Principal Investigator: Fernando Ovalle, MD | |
| Principal Investigator: Shajan Sugandha, 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, 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: Luis Balart, 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, 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: Walter Medlin, 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, 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: Vincent Aguirre, 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: | May 31, 2013 |
| 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 Diabetes Mellitus, Type 2 Obesity Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013