NCT03479671CompletedEarly phase 1
Low Dose Fat-Induced Insulin Resistance
A Dose Finding Study for Fat-Induced Insulin Resistance in Healthy Volunteers
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 20 Mar 2018
- Start date
- 1 Jan 2020
- Primary completion date
- 19 Nov 2024
- Lead sponsor
- University of Pennsylvania
- Diseases
- Type 2 diabetes
- NCT number
- NCT03479671
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 9
- From 1 Jan 2020 to the primary completion date, 19 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of tobacco within the previous year
- 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
- Use of any investigational agents within 4 weeks of enrollment
Other illness
- History of diabetes
- History of diabetes in more than one first-degree relative
- Presence of soy or egg allergies (due to possible reactions with fat infusate)
- Presence of a seizure disorder
- 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)
Lab values
- HbA1c \>5.7%
- 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).
- 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%.
- Hyperlipidemia (fasting LDL cholesterol \> 130 mg/dl, treated or untreated; and/or fasting triglycerides \> 200 mg/dl)
Other
- Body mass index (BMI) \<19 or \>27 kg/m2
- Blood Pressure: systolic \>160 mmHg or diastolic \> 100 mmHg
- 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
- Persistent elevation of liver function tests \> 1.5 times normal upper limits
Who the study is looking for
- Subjects who are able to provide written informed consent and to comply with the procedures of the study protocol
Age in the registry: 18 years to 44 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.