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Search / Trial NCT05743868

Metabolic Heterogeneity Underlying Hypertriglyceridemia: Hepatic Triglyceride Biosynthesis in Humans with Different Insulin Resistance Phenotypes

Launched by YALE UNIVERSITY · Feb 15, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how insulin resistance affects the production of triglycerides, which are a type of fat, in the liver. Researchers want to understand if resistance in specific tissues, like fat or muscle, leads to different levels of triglyceride production. They will also look at how a short exercise session might change this process in people with varying degrees of insulin resistance.

To participate, individuals need to be 18 years or older, overweight (with a body mass index between 25 and 30), and have slightly high triglyceride levels. They should also have a higher risk of insulin resistance, which means their body has trouble using insulin effectively. Participants should have stable weight for at least three months before joining the study. However, people with certain medical conditions, those taking specific medications, or those who smoke or drink excessively cannot take part. If eligible, participants can expect to contribute to important research while potentially learning more about their health and how exercise might impact their condition.

Gender

ALL

Eligibility 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.

About Yale University

Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.

Locations

Amsterdam, , Netherlands

Patients applied

0 patients applied

Trial Officials

Daniel F Vatner, MD, PhD

Principal Investigator

Yale University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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