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Duodenal Exclusion for the Treatment of Type 2 Diabetes

This study has been withdrawn prior to enrollment.
(business reasons)
Information provided by (Responsible Party):
Medtronic - MITG Identifier:
First received: September 24, 2007
Last updated: July 23, 2015
Last verified: July 2015
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
Diabetes Procedure: Duodenal Exclusion

Study Type: Interventional
Study Design: 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)

Further study details as provided by Medtronic - MITG:

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

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

Enrollment: 0
Intervention Details:
    Procedure: Duodenal Exclusion
    duodenal-jejunal bypass

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00534547

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

Responsible Party: Medtronic - MITG Identifier: NCT00534547     History of Changes
Other Study ID Numbers: AS07009
Study First Received: September 24, 2007
Last Updated: July 23, 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on August 22, 2017