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
  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:


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
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: 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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014