CompletedNCT01833403Updated Apr 20, 2017Results posted

Metabolomic Analysis of Hepatic Insulin Resistance

An interventional study of Hyperinsulinemic-euglycemic clamp in Type 2 Diabetes and Obesity, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-20.

Sponsored by University of Minnesota · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 4
Allocation: Not applicable
Ages: 18 Years to 80 Years
Sex: All

Study 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 studied

Type 2 Diabetes
Obesity

Browse trials for

Insulin Resistance 1,960

Keywords

bariatric surgery, l
liver insulin resistance,

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's enrollment of 4 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 4 participants (actual)

Study arms

Other
Measurement of insulin sensitivity
All participants will undergo a hyperinsulinemic-euglycemic clamp to measure insulin sensitivity
Other: Hyperinsulinemic-euglycemic clamp

Interventions

OtherHyperinsulinemic-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 --------------------------------------------------------------------------------
Also known as: glucose clamp

What researchers measure

Primary outcomes

Insulin Sensitivity
Time frame: 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
Time frame: 1 month

Results

Posted Jun 16, 2015

Participant flow

Participant flow — Overall Study
Milestone	Hyperinsulinemic-euglycemic Clamp
Started	4
Completed	4
Not completed	0

Outcome measures

PrimaryInsulin Sensitivity

Time frame:: Baseline
Reported as:: Mean · m value

Insulin Sensitivity
m value	Hyperinsulinemic-euglycemic Clamp
Insulin Sensitivity	8 ± 2

Statistical analysis

Hyperinsulinemic-euglycemic Clamp · t-test, 2 sided · p = <0.05

PrimaryInsulin 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

Time frame:: 1 month
Reported as:: Mean · mg glucose /kg FFM/min

Insulin Sensitivity
mg glucose /kg FFM/min	Measurement of Insulin Sensitivity
Insulin Sensitivity	8.5 ± 2

Adverse events

Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Hyperinsulinemic-euglycemic Clamp	—	0/4 (0%)	0/4 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Hyperinsulinemic-euglycemic Clamp
<=18 years	0
Between 18 and 65 years	4
>=65 years	0

Age, Continuous
Age, Continuous(years)	Hyperinsulinemic-euglycemic Clamp
Mean	40 ± 4

Sex: Female, Male
Sex: Female, Male(Participants)	Hyperinsulinemic-euglycemic Clamp
Female	4
Male	0

Region of Enrollment
Region of Enrollment(participants)	Hyperinsulinemic-euglycemic Clamp
United States	4

insulin sensitivity
insulin sensitivity(HOMA IR)	Hyperinsulinemic-euglycemic Clamp
Mean	3.55 ± 2.9

Study locations

1 site

University of Minnesota
Minneapolis, Minnesota 55455, United States

References and documents

Individual participant data

Plan to share: No — Data too small (n=4) to be shared publicly, although we will share deidentified data upon case-by-case request

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01833403
Lead sponsor: University of Minnesota
Responsible party: Sponsor
First posted: Apr 16, 2013
Start date: Apr 2013
Primary completion: Mar 2014
Completion: Mar 2014
Results posted: Jun 16, 2015
Last update: Apr 20, 2017

Study contacts

Lisa Chow, MD

principal investigator · University of Minnesota

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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