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Duodenal Exclusion for the Treatment of T2DM

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00456352
First Posted: April 4, 2007
Last Update Posted: August 22, 2014
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.
Information provided by (Responsible Party):
Medtronic - MITG
  Purpose
Evaluation of duodenal exclusion procedure for the treatment of T2DM

Condition Intervention Phase
Diabetes Procedure: duodenal exclusion Phase 4

Study Type: Interventional
Study Design: 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)

Further study details as provided by Medtronic - MITG:

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

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

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)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Locations
Brazil
Hospital São Camilo
San Paulo, Brazil
Sponsors and Collaborators
Medtronic - MITG
Investigators
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 Submitted: April 2, 2007
First Posted: April 4, 2007
Last Update Posted: August 22, 2014
Last Verified: August 2014


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