Status:
RECRUITING
Low Dose Fat-Induced Insulin Resistance
Lead Sponsor:
University of Pennsylvania
Conditions:
Diabetes Mellitus, Type 2
Insulin Resistance
Eligibility:
All Genders
18-44 years
Phase:
EARLY_PHASE1
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 (Intral...
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 ...
Eligibility Criteria
Inclusion
- Subjects who are able to provide written informed consent and to comply with the procedures of the study protocol
Exclusion
- 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%.
- 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)
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03479671
Start Date
January 1 2020
End Date
January 1 2026
Last Update
March 11 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104