Metabolomic Analysis of Hepatic Insulin Resistance

Completed · Not applicable

Conditions studied: Type 2 Diabetes, Obesity

In brief

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 more about nonalcoholic fatty liver disease (NFLD). Nonalcoholic fatty liver disease is the accumulation of fat in the liver of people who have minimal alcohol exposure. Nonalcoholic Fatty Liver Disease is associated with obesity and insulin resistance, and predicts development of Type 2 Diabetes. The study doctors are interested in looking at the relationship between liver fat and insulin resistance.

Key facts

Study ID

NCT01833403

Run by

University of Minnesota

People needed

4

Starts

2013-04-01

Expected to finish

2014-03-01

Last updated by the study team

2017-04-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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