Low Dose Fat-Induced Insulin Resistance

Description

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

Study Overview

Study Details

Study overview

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.

A Dose Finding Study for Fat-Induced Insulin Resistance in Healthy Volunteers

Low Dose Fat-Induced Insulin Resistance

Condition
Diabetes Mellitus, Type 2
Intervention / Treatment

-

Contacts and Locations

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 44 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Pennsylvania,

Zoltan P Arany, MD, PhD, PRINCIPAL_INVESTIGATOR, Associate Professor of Medicine

Study Record Dates

2026-01