Metabolomic Analysis of Hepatic Insulin Resistance

Obesity Clinical Trial

Official title:

Metabolomic Analysis of Hepatic Insulin Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833403
• Other study ID #: 1211M23881
• Status: Completed
• Phase: N/A
• First received: April 10, 2013
• Last updated: May 29, 2015
• Start date: April 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Subjects eligible to participate in the study will be:

1. Adults over age 18;

2. Patients enrolled in the bariatric surgery clinic who are planning to undergo and have insurance approval for bariatric surgery;

3. 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)

4. Able and willing to give informed consent.

Exclusion Criteria

The following will exclude subjects from study participation:

1. 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.

2. 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]).

3. 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.

4. Inflammatory or celiac intestinal disease;

5. Untreated thyroid disease;

6. Excessive alcohol use, illicit drug use, or active untreated psychiatric disease.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Type 2 Diabetes

Intervention

Device:
• Hyperinsulinemic-euglycemic clamp
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

Drug:
• Glucose

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity		Baseline	No