Duodenal Exclusion for the Treatment of T2DM

August 21, 2014 updated by: Medtronic - MITG

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

Evaluation of duodenal exclusion procedure for the treatment of T2DM

Study Overview

Status

Completed

Conditions

Diabetes

Intervention / Treatment

Procedure: duodenal exclusion

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Brazil
- - San Paulo, Brazil
    - Hospital São Camilo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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 Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment success based on patients' glycemic control. Time Frame: 2 weeks, 3 months, 6 months, 9 months, 12 months	2 weeks, 3 months, 6 months, 9 months, 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Physiologic measurements, Comorbidity improvement, Improvement in QOL. Time Frame: 2 weeks, 3 months, 6 months, 9 months, 12 months	2 weeks, 3 months, 6 months, 9 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Investigators

Study Director: Noreen A Gannon, Medtronic - MITG
Principal Investigator: Ricardo Cohen, MD, Hospital São Camilo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

April 2, 2007

First Submitted That Met QC Criteria