NCT00534547

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
Last Updated

July 27, 2015

Status Verified

July 1, 2015

First QC Date

September 24, 2007

Last Update Submit

July 23, 2015

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Treatment success based on patients' glycemic control

    12 Months

Secondary Outcomes (1)

  • Physiologic Measurements, Comorbidity improvement, Improvement in QOL

    12 Months

Interventions

Duodenal ExclusionPROCEDURE

duodenal-jejunal bypass

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Noreen Fahey

    Medtronic - MITG

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Last Updated

July 27, 2015

Record last verified: 2015-07