Understanding how different types of insulin resistance affect fat production in the liver
Metabolic Heterogeneity Underlying Hypertriglyceridemia: Hepatic Triglyceride Biosynthesis in Humans With Different Insulin Resistance Phenotypes
NA · Yale University · NCT05743868
This study is trying to see how different types of insulin resistance affect fat production in the liver, especially looking at how exercise before meals influences people with muscle-only resistance compared to those with both muscle and fat resistance.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Yale University (other) |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05743868 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of tissue-specific insulin resistance on liver fat production in humans. It aims to differentiate between individuals with muscle-only insulin resistance and those with combined muscle and adipose insulin resistance, particularly focusing on how these groups respond to premeal exercise. By analyzing the mechanisms behind triglyceride overproduction, the study seeks to uncover the relationship between insulin resistance phenotypes and hepatic triglyceride biosynthesis. The primary endpoints include measuring the percentage of lipids derived from de novo lipogenesis in these different groups.
Who should consider this trial
Good fit: Ideal candidates are overweight individuals with modest hypertriglyceridemia and a high risk of insulin resistance.
Not a fit: Patients with active or chronic liver disease, kidney disease, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored interventions for managing hypertriglyceridemia and insulin resistance.
How similar studies have performed: While there have been studies on insulin resistance and triglyceride metabolism, this specific approach focusing on tissue-specific insulin resistance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to give informed consent * Overweight, defined as BMI 25-30 kg/m2 * Modest hypertriglyceridemia, defined as fasting plasma triglycerides 1.5-3.0mM * High risk of insulin resistance, defined as fasting plasma insulin \>64pM * Stable weight for at least 3mo prior to participation Exclusion Criteria: * Active or chronic liver disease, kidney disease, congestive heart failure, unstable angina, history of acute cardiovascular events within 6mo of screening, history of seizures or syncope, or an active infection requiring antimicrobial therapy; * Use of insulin, thiazolidinediones, SGLT2 inhibitors, or sulfonylureas; * Use of fibrates, omega 3 (fish oil), niacin, or PCSK9 antagonists; * Use of systemic glucocorticoids within 60d prior to participation; * Hematocrit \<35%; * Pregnancy of breastfeeding; * Active tobacco use, excessive alcohol intake (\>14U/wk), or history of drug abuse.
Where this trial is running
Amsterdam
- AMC Amsterdam — Amsterdam, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Daniel F Vatner, MD, PhD — Yale University
- Study coordinator: Daniel F Vatner, MD, PhD
- Email: daniel.vatner@yale.edu
- Phone: 203 785 5934
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.
Conditions: Insulin Resistance, Hypertriglyceridemia