Status:
COMPLETED
Duodenal Exclusion for the Treatment of T2DM
Lead Sponsor:
Medtronic - MITG
Conditions:
Diabetes
Eligibility:
All Genders
20-60 years
Phase:
PHASE4
Brief Summary
Evaluation of duodenal exclusion procedure for the treatment of T2DM
Eligibility Criteria
Inclusion
- Age between 20 and 65 years
- BMI between 23 and 34
- Oral agents or insulin to control T2DM
- Inadequate control of diabetes as defined as HbA1c \>/ 7.5
- Understanding of the mechanisms of action of the treatment
Exclusion
- More than 10 years of T2DM diagnosis
- More than 7 years of insulin use
- Previous abdominal operations
- Coagulopathy
- Liver cirrhosis
- Unable to comply with study requirements, follow-up schedule or give valid consent.
- Currently pregnant.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00456352
Start Date
April 1 2007
End Date
October 1 2010
Last Update
August 22 2014
Active Locations (1)
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1
Hospital São Camilo
São Paulo, Brazil