Metabolomic Analysis of Hepatic Insulin Resistance

Study Overview
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Brief Summary
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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.

Official Title
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Metabolomic Analysis of Hepatic Insulin Resistance

Conditions
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Type 2 Diabetes, Obesity

Intervention / Treatment
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* Other: Hyperinsulinemic-euglycemic clamp


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Measurement of insulin sensitivity<br>All participants will undergo a hyperinsulinemic-euglycemic clamp to measure insulin sensitivity | Other: Hyperinsulinemic-euglycemic clamp<br>* Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery --------------------------------------------------------------------------------<br>* Other names: glucose clamp;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Sensitivity |  | Baseline | 
| Insulin Sensitivity | Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 150-180 minute interval of the clamp | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, l, liver insulin resistance,