Duodenal Exclusion for the Treatment of Type 2 Diabetes

This study has been terminated.

( business reasons )

First Received: September 24, 2007 Last Updated: November 14, 2008 History of Changes

Sponsored by:	Covidien
Information provided by:	Covidien
ClinicalTrials.gov Identifier:	NCT00534547

Purpose

The purpose of this study is to investigate the role of an experimental surgery that may offer better short and long-term control of T2DM in select patients who have not achieved adequate blood sugar control with regular means.

Condition	Intervention	Phase
Diabetes	Procedure: Duodenal Exclusion	Phase IV

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase IV Study of Duodenal Exclusion for the Treatment of Type 2 Diabetes (T2DM)

Further study details as provided by Covidien:

Primary Outcome Measures:

Treatment success based on patients' glycemic control [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physiologic Measurments, Comorbidity improvement, Improvement in QOL [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	October 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

duodenal-jejunal bypass

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Age between 20 and 50 years old;
BMI between 27 and 34.9;
Oral agents or insulin to control T2DM;
Inadequate control of diabetes as defined as HbA1c>8.0% but <10%
Understanding of the mechanisms of action of the treatment

Exclusion criteria:

More than 5 years of T2DM diagnosis;
C-peptide <1pg/ml (off insulin)
Previous abdominal operations;
History of gastritis
History of GERD
History of peptic ulcer disease
Inflammatory bowel disease
Coagulopathy;
Liver cirrosis;
Unable to comply with study requirements, follow-up schedule or give valid informed consent;
Currently pregnant (pregnancy test required for confirmation for those of child bearing years)
Patient is not available for programmed follow-up during the study period
Patient is unwilling to forgo good samaritan blood donation during the study period

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534547

Locations

United States, Massachusetts
Tufts New England Medical Center
Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

Covidien

Investigators

Study Director:

Noreen Fahey

Covidien

More Information

No publications provided

Responsible Party:	Tufts New England Medical Center ( Michael Tarnoff, MD )
Study ID Numbers:	AS07009
Study First Received:	September 24, 2007
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00534547 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009