Low Dose Fat-Induced Insulin Resistance
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus - Type 2
- Insulin Resistance
- Insulin Sensitivity
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Baseline insulin sensitivity will be measured in healthy volunteers, and then 1-3 weeks later insulin sensitivity will be measured in response to a low-dose fatty acid infusion. If there is no response to this low-dose infusion, then 1-3 weeks later insulin sensitivity will be measured in response to a medium-dose fatty acid infusion.Masking: None (Open Label)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 39 years
- Gender
- Both males and females
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 free-fatty acid induced insulin resistance. Healthy male and healthy female volunteers will undergo ...
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 free-fatty acid induced insulin resistance. Healthy male and healthy female volunteers will undergo a 6 hour hyperinsulinemic-euglycemic clamp, in order to establish insulin sensitivity parameters in the presence of fatty acid co-infusion. The subjects will then return 1-3 weeks later, and undergo another 6 hour HIE clamp, this time in the presence of low-dose fatty acid co-infusion (30ml/hr). If this dose does not achieve ~25% reduction in the rate of glucose disposal, then the dose-confirmation study will be repeated 1-3 weeks later with a medium-dose fatty acid co-infusion (60ml/hr). A dose-response effect of fatty acids on insulin resistance has been demonstrated before, but not in the precise conditions of our study. This dose-finding study is critical because future studies require a reliable dose of fatty acid infusion, and the exact dose of fatty acid infusion that causes mild insulin resistance may be different in the conditions of our study.
Tracking Information
- NCT #
- NCT03479671
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Zoltan P Arany, MD, PhD Associate Professor of Medicine
Get Well Soon