Status:
COMPLETED
Improving Diabetes After Bariatric Surgery
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Diabetes
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this project is to examine the physical mechanisms that contribute to improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of bariatric surgery.
Detailed Description
The goal of this project is to examine the physiological mechanisms that contribute to improvements of glucose homeostasis in type 2 diabetes mellitus (DM) following gastric bypass Roux-en-Y bariatric...
Eligibility Criteria
Inclusion
- Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon.
- 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
- Informed consent not obtained.
- 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).
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00676923
Start Date
March 1 2008
End Date
October 1 2012
Last Update
November 14 2012
Active Locations (5)
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1
Legacy Good Samaritan Hospital
Portland, Oregon, United States
2
Oregon Health and Science University
Portland, Oregon, United States
3
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
4
University of Washington
Seattle, Washington, United States, 98195