Low Dose Fat-Induced Insulin Resistance

NCT03479671 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 831425
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Insulin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  Rate of Glucose Disposal (mg/kg/min)

  6 hours

Study Arms (3)

Saline

NO INTERVENTION

Insulin sensitivity (rate of glucose disposal)

Low Dose Fatty Acids

EXPERIMENTAL

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

Drug: Intralipid, 20% Intravenous Emulsion

Medium Dose Fatty Acids

EXPERIMENTAL

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

Drug: Intralipid, 20% Intravenous Emulsion

Interventions

Intralipid, 20% Intravenous Emulsion DRUG

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

Low Dose Fatty Acids; Medium Dose Fatty Acids

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: Male or Female at birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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:
• history of myocardial infarction within past 6 months;
• history of ischemia on functional cardiac exam within the last year;
• history of left ventricular ejection fraction \< 30%.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

soybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Zoltan P Arany, MD, PhD

  Associate Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Of Medicine

Model Details: Baseline insulin sensitivity will be measured in healthy volunteers, and then 1-3 weeks later insulin sensitivity will be measured in response to a low-dose fatty acid infusion. If there is no response to this low-dose infusion, then 1-3 weeks later insulin sensitivity will be measured in response to a medium-dose fatty acid infusion.

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: January 1, 2020
• Primary Completion: November 19, 2024
• Study Completion: November 19, 2024
• Last Updated: April 15, 2026

Record last verified: 2026-02

Locations

US (1)