Text Size

Duodenal Exclusion for the Treatment of Type 2 Diabetes

This study has been terminated.
(business reasons)
Sponsor:
Information provided by:
Covidien
ClinicalTrials.gov Identifier:
NCT00534547
First received: September 24, 2007
Last updated: November 14, 2008
Last verified: November 2008
History of Changes
  Purpose

The purpose of this study is to investigate the role of an experimental surgery that may offer better short and long-term control of T2DM in select patients who have not achieved adequate blood sugar control with regular means.


Condition Intervention Phase
Diabetes
 Procedure: Duodenal Exclusion
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Study of Duodenal Exclusion for the Treatment of Type 2 Diabetes (T2DM)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Covidien:

Primary Outcome Measures:
  • Treatment success based on patients' glycemic control [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physiologic Measurments, Comorbidity improvement, Improvement in QOL [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2007
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Duodenal Exclusion
    duodenal-jejunal bypass
  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age between 20 and 50 years old;
  • BMI between 27 and 34.9;
  • Oral agents or insulin to control T2DM;
  • Inadequate control of diabetes as defined as HbA1c>8.0% but <10%
  • Understanding of the mechanisms of action of the treatment

Exclusion criteria:

  • More than 5 years of T2DM diagnosis;
  • C-peptide <1pg/ml (off insulin)
  • Previous abdominal operations;
  • History of gastritis
  • History of GERD
  • History of peptic ulcer disease
  • Inflammatory bowel disease
  • Coagulopathy;
  • Liver cirrosis;
  • Unable to comply with study requirements, follow-up schedule or give valid informed consent;
  • Currently pregnant (pregnancy test required for confirmation for those of child bearing years)
  • Patient is not available for programmed follow-up during the study period
  • Patient is unwilling to forgo good samaritan blood donation during the study period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534547

Locations
United States, Massachusetts
Tufts New England Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Covidien
Investigators
Study Director: Noreen Fahey Covidien
  More Information

No publications provided

Responsible Party: Michael Tarnoff, MD, Tufts New England Medical Center
ClinicalTrials.gov Identifier: NCT00534547     History of Changes
Other Study ID Numbers: AS07009
Study First Received: September 24, 2007
Last Updated: November 14, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013