Duodenal Exclusion for the Treatment of T2DM

Diabetes Clinical Trial

Official title:

Phase IV Study of Duodenal Exclusion for the Treatment of Type 2 Diabetes Mellitus (T2DM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456352
• Other study ID #: AS07004
• Status: Completed
• Phase: Phase 4
• First received: April 2, 2007
• Last updated: August 21, 2014
• Start date: April 2007
• Est. completion date: October 2010

Study information

• Verified date: August 2014
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Evaluation of duodenal exclusion procedure for the treatment of T2DM

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Procedure:
• duodenal exclusion

Locations

Country	Name	City	State
Brazil	Hospital São Camilo	San Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment success based on patients' glycemic control.		2 weeks, 3 months, 6 months, 9 months, 12 months	Yes
Secondary	Physiologic measurements, Comorbidity improvement, Improvement in QOL.		2 weeks, 3 months, 6 months, 9 months, 12 months	Yes