Duodenal Exclusion for the Treatment of T2DM

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00456352
First received: April 2, 2007
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

Evaluation of duodenal exclusion procedure for the treatment of T2DM


Condition Intervention Phase
Diabetes
Procedure: duodenal exclusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Study of Duodenal Exclusion for the Treatment of Type 2 Diabetes Mellitus (T2DM)

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Treatment success based on patients' glycemic control. [ Time Frame: 2 weeks, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Physiologic measurements, Comorbidity improvement, Improvement in QOL. [ Time Frame: 2 weeks, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: April 2007
Study Completion Date: October 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456352

Locations
Brazil
Hospital São Camilo
San Paulo, Brazil
Sponsors and Collaborators
Covidien
Investigators
Study Director: Noreen A Gannon Covidien
Principal Investigator: Ricardo Cohen, MD Hospital São Camilo
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT00456352     History of Changes
Other Study ID Numbers: AS07004
Study First Received: April 2, 2007
Last Updated: August 21, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 14, 2014