Duodenal Exclusion for the Treatment of T2DM

Phase 4

Completed

• Conditions: Diabetes

• Registration Number: NCT00456352
• Lead Sponsor: Medtronic - MITG

Brief Summary

Evaluation of duodenal exclusion procedure for the treatment of T2DM

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-02
• Study First Submitted QC: 2007-04-02
• Study First Posted: 2007-04-04
• Primary Completion: 2009-04
• Study Completion: 2010-10
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-21
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Treatment success based on patients' glycemic control.	2 weeks, 3 months, 6 months, 9 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Physiologic measurements, Comorbidity improvement, Improvement in QOL.	2 weeks, 3 months, 6 months, 9 months, 12 months

Trial Locations

Locations (1)

Hospital São Camilo; 🇧🇷 San Paulo, Brazil