Duodenal Exclusion for the Treatment of T2DM

Medtronic

Status and phase: Completed; Phase 4

Conditions: Diabetes

Treatments: Procedure: duodenal exclusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00456352

AS07004

Details and patient eligibility

About

Evaluation of duodenal exclusion procedure for the treatment of T2DM

Enrollment: 37 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)