Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
63 participants
OBSERVATIONAL
2008-03-31
2012-10-31
Brief Summary
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Detailed Description
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Funds are not available to pay for the surgery for patients, only to address research questions.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Enrollment in LABS-1 or LABS-2.
* Documented type 2 diabetes (fasting plasma glucose greater than 125 mg/dl) that is treated with lifestyle efforts (drug naïve) or taking acceptable oral medications (see appendix) with a HgA1c less than or equal to 8.5% and a fasting blood glucose less than or equal to 180 mg/dL. This will be one group.
* Non-diabetic (ND) with normal values for fasting glucose and HbA1c. This will be the second group.
* Adequate IV access.
Exclusion Criteria
* Patient with diabetes with an HbA1c greater than 8.5% or a fasting blood glucose greater than 180 mg/dL.
* Creatinine greater than 1.7.
* Unlikely to comply with the 6 month follow-up (post-surgical) protocol (i.e. geographically inaccessible for study visits) or unable to communicate with local study staff.
* Use of unacceptable diabetic medications (see appendix) at baseline (see appendix).
18 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Principal Investigators
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Jonathan Purnell, MD
Role: STUDY_DIRECTOR
Oregon Health and Science University
Locations
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Legacy Good Samaritan Hospital
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Washington
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Countries
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Related Links
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Related Info
Other Identifiers
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DK6657_3b
Identifier Type: -
Identifier Source: org_study_id