Low Dose Fat-Induced Insulin Resistance

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Insulin; Insulin, Globin Zinc; Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

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

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)