Status:
COMPLETED
Bariatric Surgery And Adipose Inflammation Dysfunction and Type 2 Diabetes Mellitus
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
American Diabetes Association
Conditions:
Type 2 Diabetes Mellitus
Insulin Resistance
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The focus of this proposal is to define the mechanism by which bariatric surgery acutely improves insulin sensitivity. Our central hypothesis is that drastically reduced caloric intake early after Bar...
Detailed Description
Bariatric surgery quickly improves tissue specific insulin sensitivity. Changes in glucose metabolism are seen within days after surgery, prior to any significant weight loss--raising the question of ...
Eligibility Criteria
Inclusion
- Inclusion Criteria::
- Candidate for RYGB gastric bypass with insurance approval.
- Willing to accept randomization to either immediate surgery, or delayed surgery after diet study.
- Willing to undergo two sessions of testing before, and ten days after surgery (or initiation of dietary intervention).
- BMI 35-45kg/m2
- Pre-diabetes (ADA criteria) or T2DM with HbA1c\< 8%.
- Exclusion criteria:
- T1DM.
- Serious illness such as cancer, active chronic infection, cardiovascular disease greater that New York Heart Association class 2, chronic renal failure, chronic lung disease.
- Inflammatory or celiac intestinal disease.
- Untreated thyroid disease.
- Serious psychiatric disease.
- Excessive alcohol use.
- Illicit drug use. -
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2018
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01882036
Start Date
November 1 2011
End Date
July 10 2018
Last Update
February 14 2023
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455