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Duodenal Exclusion for the Treatment of T2DM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00456352
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : August 22, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
Evaluation of duodenal exclusion procedure for the treatment of T2DM

Condition or disease Intervention/treatment Phase
Diabetes Procedure: duodenal exclusion Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Study of Duodenal Exclusion for the Treatment of Type 2 Diabetes Mellitus (T2DM)
Study Start Date : April 2007
Primary Completion Date : April 2009
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Treatment success based on patients' glycemic control. [ Time Frame: 2 weeks, 3 months, 6 months, 9 months, 12 months ]

Secondary Outcome Measures :
  1. Physiologic measurements, Comorbidity improvement, Improvement in QOL. [ Time Frame: 2 weeks, 3 months, 6 months, 9 months, 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456352

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

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT00456352     History of Changes
Other Study ID Numbers: AS07004
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: August 22, 2014
Last Verified: August 2014