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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

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

No

Genders Eligible for Study

All

Description

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 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

April 2, 2007

First Posted (Estimate)

April 4, 2007

Study Record Updates

Last Update Posted (Estimate)

August 22, 2014

Last Update Submitted That Met QC Criteria

August 21, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • AS07004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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