Metabolomic Analysis of Hepatic Insulin Resistance

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Type 2 Diabetes
• Intervention / Treatment: Other: Hyperinsulinemic-euglycemic clamp

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Measurement of insulin sensitivity; All participants will undergo a hyperinsulinemic-euglycemic clamp to measure insulin sensitivity	Other: 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 --------------------------------------------------------------------------------; Other Names: glucose clamp

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Lisa Chow, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: April 10, 2013
• First Submitted That Met QC Criteria: April 15, 2013
• First Posted (ESTIMATE): April 16, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2017
• Last Update Submitted That Met QC Criteria: March 22, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: bariatric surgery, l; liver insulin resistance,
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: 1211M23881

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data too small (n=4) to be shared publicly, although we will share deidentified data upon case-by-case request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No