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Metabolomic Analysis of Hepatic Insulin Resistance

Primary Purpose

Type 2 Diabetes, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hyperinsulinemic-euglycemic clamp

About this trial

This is an interventional diagnostic trial for Type 2 Diabetes focused on measuring bariatric surgery, l, liver insulin resistance,

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Minnesota

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Measurement of insulin sensitivity

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01833403

First Posted

April 10, 2013

Last Updated

March 22, 2017

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT01833403

Brief Title

Metabolomic Analysis of Hepatic Insulin Resistance

Official Title

Metabolomic Analysis of Hepatic Insulin Resistance

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Obesity

Keywords

bariatric surgery, l, liver insulin resistance,

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Measurement of insulin sensitivity

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Hyperinsulinemic-euglycemic clamp

Other Intervention Name(s)

glucose clamp

Intervention Description

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 --------------------------------------------------------------------------------

Primary Outcome Measure Information:

Title

Insulin Sensitivity

Time Frame

Baseline

Title

Insulin Sensitivity

Description

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisa Chow, MD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data too small (n=4) to be shared publicly, although we will share deidentified data upon case-by-case request

Learn more about this trial

Metabolomic Analysis of Hepatic Insulin Resistance

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