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CompletedNCT03479671BCAAUpdated Apr 15, 2026

Low Dose Fat-Induced Insulin Resistance

An Early Phase 1 interventional study of Intralipid, 20% Intravenous Emulsion in Diabetes Mellitus, Type 2, Insulin Resistance and Insulin Sensitivity, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by University of Pennsylvania · Early Phase 1, Interventional, and Basic science

Phase
Early Phase 1
Study type
Interventional
Enrollment
9
Allocation
Non-randomized
Ages
18 Years to 44 Years
Sex
All
01

Study summary

The primary goal of this study is to determine the dose of fatty acids that acutely induces mild insulin resistance in healthy volunteers. We hypothesize that a low-dose of fatty acid infusion (Intralipid/heparin) will cause a mild insulin resistance. The dose of fatty acid infusion that reliably causes mild insulin resistance will be selected for use in future studies.

Read the detailed description

This study is designed to test the hypothesis that a low-dose of fatty acid infusion (Intralipid/heparin) will cause mild insulin resistance. This dose-finding study is critical for future studies on free-fatty acid induced insulin resistance.

Healthy male and healthy female volunteers will undergo a 6 hour hyperinsulinemic-euglycemic clamp, in order to establish insulin sensitivity parameters in the presence of fatty acid co-infusion. The subjects will then return 1-3 weeks later, and undergo another 6 hour HIE clamp, this time in the presence of low-dose fatty acid co-infusion (30ml/hr). If this dose does not achieve \~25% reduction in the rate of glucose disposal, then the dose-confirmation study will be repeated 1-3 weeks later with a medium-dose fatty acid co-infusion (60ml/hr).

A dose-response effect of fatty acids on insulin resistance has been demonstrated before, but not in the precise conditions of our study. This dose-finding study is critical because future studies require a reliable dose of fatty acid infusion, and the exact dose of fatty acid infusion that causes mild insulin resistance may be different in the conditions of our study.

02

Conditions studied

  • Diabetes Mellitus, Type 2
  • Insulin Resistance
  • Insulin Sensitivity
03

Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects who are able to provide written informed consent and to comply with the procedures of the study protocol

Exclusion criteria

Exclusion Criteria:

  • History of diabetes
  • History of diabetes in more than one first-degree relative
  • Body mass index (BMI) \<19 or >27 kg/m2
  • HbA1c >5.7%
  • Blood Pressure: systolic >160 mmHg or diastolic > 100 mmHg
  • Baseline hemoglobin concentration \< 11 g/dl in women and \< 12 g/dl in men
  • Estimated glomerular filtration rate \< 55 ml/min/1.73 m2 (calculated using the subject's measured serum creatinine and the Modification of Diet in Renal Disease [MDRD] study estimation formula).
  • Presence of soy or egg allergies (due to possible reactions with fat infusate)
  • For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
  • Known active alcohol or substance abuse
  • Use of tobacco within the previous year

  • Severe co-existing cardiac disease, characterized by any one of these conditions:

    1. history of myocardial infarction within past 6 months;
    2. history of ischemia on functional cardiac exam within the last year;
    3. history of left ventricular ejection fraction \< 30%.
  • Persistent elevation of liver function tests > 1.5 times normal upper limits
  • Hyperlipidemia (fasting LDL cholesterol > 130 mg/dl, treated or untreated; and/or fasting triglycerides > 200 mg/dl)
  • Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for the use of ≤ 5 mg prednisone daily, or an equivalent physiological dose of hydrocortisone
  • Presence of a seizure disorder
  • Use of any investigational agents within 4 weeks of enrollment
  • Any medical condition, which in the opinion of the investigator, will interfere with the safe completion of the study
  • History of pancreatitis
  • Presence of a metal allergy (aluminum)
04

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • No intervention
    Saline

    Insulin sensitivity (rate of glucose disposal)

  • Experimental
    Low Dose Fatty Acids

    Insulin sensitivity (rate of glucose disposal) in response to 30 ml/hr fatty acid infusion

    Drug: Intralipid, 20% Intravenous Emulsion

  • Experimental
    Medium Dose Fatty Acids

    Insulin sensitivity (rate of glucose disposal) in response to 60 ml/hr fatty acid infusion

    Drug: Intralipid, 20% Intravenous Emulsion

Interventions

  • DrugIntralipid, 20% Intravenous Emulsion

    Fatty Acid Infusion, either in low-dose (30 ml/hr) or medium-dose (60 ml/hr)

05

What researchers measure

Primary outcomes

  1. Insulin Sensitivity

    Rate of Glucose Disposal (mg/kg/min)

    Time frame: 6 hours

06

Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03479671
Lead sponsor
University of Pennsylvania
Responsible party
Zoltan Arany (Associate Professor Of Medicine, University of Pennsylvania) — Principal investigator
First posted
Mar 27, 2018
Start date
Jan 1, 2020
Primary completion
Nov 19, 2024
Completion
Nov 19, 2024
Last update
Apr 15, 2026

Study contacts

Zoltan P Arany, MD, PhD
principal investigator · Associate Professor of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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