Duodenal Exclusion for the Treatment of Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00534547
Recruitment Status : Withdrawn (business reasons)
First Posted : September 26, 2007
Last Update Posted : July 27, 2015
Information provided by (Responsible Party):
Medtronic - MITG

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Procedure: Duodenal Exclusion Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Study of Duodenal Exclusion for the Treatment of Type 2 Diabetes (T2DM)

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Procedure: Duodenal Exclusion
    duodenal-jejunal bypass

Primary Outcome Measures :
  1. Treatment success based on patients' glycemic control [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. Physiologic Measurements, Comorbidity improvement, Improvement in QOL [ Time Frame: 12 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 cirrhosis;
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00534547

Sponsors and Collaborators
Medtronic - MITG
Study Director: Noreen Fahey Medtronic - MITG

Responsible Party: Medtronic - MITG Identifier: NCT00534547     History of Changes
Other Study ID Numbers: AS07009
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015

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