Infusion of low-dose fatty acids to study insulin resistance
A Dose Finding Study for Fat-Induced Insulin Resistance in Healthy Volunteers
This study is testing how different doses of fatty acids can affect insulin resistance in healthy volunteers to help understand this condition better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT03479671 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the specific dose of fatty acids that can induce mild insulin resistance in healthy volunteers. Participants will undergo a hyperinsulinemic-euglycemic clamp procedure to measure insulin sensitivity, first without and then with a low-dose fatty acid infusion. If the initial dose does not achieve the desired reduction in glucose disposal, a medium-dose infusion will be tested in subsequent visits. This dose-finding approach is essential for establishing a reliable protocol for future studies on fatty acid-induced insulin resistance.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male and female volunteers with a BMI between 19 and 27 kg/m2 who can provide informed consent.
Not a fit: Patients with a history of diabetes or related conditions, as well as those with certain health exclusions, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the mechanisms of insulin resistance, potentially leading to improved treatments for type 2 diabetes.
How similar studies have performed: Previous studies have demonstrated a dose-response effect of fatty acids on insulin resistance, but this specific approach is novel in its precise conditions.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Zoltan P Arany, MD, PhD — Associate Professor of Medicine
- Study coordinator: Paola Alvarado, MS
- Email: Paola.Alvarado@Pennmedicine.upenn.edu
- Phone: 215-746-2081
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.