Status:
COMPLETED
Metabolomic Analysis of Hepatic Insulin Resistance
Lead Sponsor:
University of Minnesota
Conditions:
Type 2 Diabetes
Obesity
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a pilot study to show that it is possible to identify the specific types of fats in blood, adipose tissue, and liver tissue. The study doctors hope to use the analysis of these fats to learn m...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects eligible to participate in the study will be:
- Adults over age 18;
- Patients enrolled in the bariatric surgery clinic who are planning to undergo and have insurance approval for bariatric surgery;
- Insulin sensitive (based on HOMA-IR calculated from screening labs) OR insulin resistant (based on HOMA-IR and or personal history of diet controlled diabetes)
- Able and willing to give informed consent.
- Exclusion Criteria
- The following will exclude subjects from study participation:
- Clinically significant medical issues outside of diabetes (eg, pregnancy, cardiovascular disease, uncontrolled pulmonary disease). If female and of child bearing potential, a pregnancy test will be performed and confirmed negative prior to participation in the study and prior to the scheduled glucose clamp procedure.
- A history of hematologic (platelets \<100 x107/L), hepatic (liver function tests \[LFTs\] \>2X upper limit of normal), renal (Creatinine \>1.5 mg/dL), pulmonary/ cardiac abnormalities (ie, abnormal electrocardiogram \[EKG\]).
- Use of anti-diabetes medication, anticoagulants, or medication that might alter lipids. If the subject has a history of diabetes, it should be controlled by diet alone.
- Inflammatory or celiac intestinal disease;
- Untreated thyroid disease;
- Excessive alcohol use, illicit drug use, or active untreated psychiatric disease.
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01833403
Start Date
April 1 2013
End Date
March 1 2014
Last Update
April 20 2017
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455