Metabolomic Analysis of Hepatic Insulin Resistance

NCT01833403 | Completed Results

• 1 other identifier: 1211M23881
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Type 2 Diabetes; Obesity

Keywords

bariatric surgery, l; liver insulin resistance,

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Measurement of insulin sensitivity

OTHER

All participants will undergo a hyperinsulinemic-euglycemic clamp to measure insulin sensitivity

Other: Hyperinsulinemic-euglycemic clamp

Interventions

Hyperinsulinemic-euglycemic clamp OTHER

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 \--------------------------------------------------------------------------------

Also known as: glucose clamp

Measurement of insulin sensitivity

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Glucose Clamp Technique

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Lisa Chow MD
• Organization: University of Minnesota

chow0007@umn.edu

612-625-8934

Study Officials

• Lisa Chow, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: April 16, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 20, 2017
• Results First Posted: June 16, 2015

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)