Low Dose Fat-Induced Insulin Resistance

Launched by UNIVERSITY OF PENNSYLVANIA · Mar 20, 2018

Keywords

ClinConnect Summary

This clinical trial is studying how a low dose of fatty acids affects insulin resistance in healthy individuals. Insulin resistance is a condition where the body does not respond properly to insulin, which can be a concern for people with diabetes. The researchers want to find out the exact dose of fatty acid infusion that can cause a mild form of insulin resistance. This information will help in designing future studies aimed at understanding diabetes better.

To participate in this study, volunteers should be between the ages of 65 and 70 and must be able to give their consent and follow the study's procedures. However, people with a history of diabetes, certain medical conditions, or specific allergies will not be eligible to join. If selected, participants can expect to receive a fatty acid infusion and will be monitored closely to see how their body responds. This trial is currently recruiting participants, and it could provide valuable insights into how diet impacts insulin sensitivity and diabetes management.

Gender

ALL

Eligibility 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)