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

Duodenal Exclusion for the Treatment of T2DM

This study has been completed.
Information provided by (Responsible Party):
Covidien Identifier:
First received: April 2, 2007
Last updated: August 21, 2014
Last verified: August 2014

Evaluation of duodenal exclusion procedure for the treatment of T2DM

Condition Intervention Phase
Procedure: duodenal exclusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 Mellitus (T2DM)

Further study details as provided by Covidien:

Primary Outcome Measures:
  • Treatment success based on patients' glycemic control. [ Time Frame: 2 weeks, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Physiologic measurements, Comorbidity improvement, Improvement in QOL. [ Time Frame: 2 weeks, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: April 2007
Study Completion Date: October 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age between 20 and 65 years
  2. BMI between 23 and 34
  3. Oral agents or insulin to control T2DM
  4. Inadequate control of diabetes as defined as HbA1c >/ 7.5
  5. Understanding of the mechanisms of action of the treatment

Exclusion Criteria:

  1. More than 10 years of T2DM diagnosis
  2. More than 7 years of insulin use
  3. Previous abdominal operations
  4. Coagulopathy
  5. Liver cirrhosis
  6. Unable to comply with study requirements, follow-up schedule or give valid consent.
  7. Currently pregnant.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00456352

Hospital São Camilo
San Paulo, Brazil
Sponsors and Collaborators
Study Director: Noreen A Gannon Covidien
Principal Investigator: Ricardo Cohen, MD Hospital São Camilo
  More Information

No publications provided

Responsible Party: Covidien Identifier: NCT00456352     History of Changes
Other Study ID Numbers: AS07004
Study First Received: April 2, 2007
Last Updated: August 21, 2014
Health Authority: Brazil: National Committee of Ethics in Research processed this record on March 03, 2015