Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID05743868

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

Led by Yale University · Updated on 2026-01-27

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

A

Amsterdam UMC

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how different types of insulin resistance affect the way the liver produces triglycerides in people with insulin resistance and hypertriglyceridemia. The study compares individuals with insulin resistance in both muscle and fat tissues to those with insulin resistance mainly in muscle tissue. It also evaluates how a short exercise session before a meal influences liver triglyceride production in these groups. Participants will undergo two main interventions: a standardized dinner to assess liver triglyceride production and a standardized dinner combined with short premeal exercise sessions. Insulin sensitivity in muscle and fat tissues, glucose tolerance, and the contribution of newly made fats (de novo lipogenesis) to liver triglycerides will be measured. Blood samples will be collected the morning after the dinner to measure these effects, with a washout period between two study visits. During the study, participants will have their insulin sensitivity and blood triglyceride levels tested using oral glucose tolerance tests and blood draws. Researchers will track changes in triglyceride production and insulin resistance at baseline and after exercise interventions. The study will last up to eight weeks, with blood tests and metabolic assessments conducted at two study visits to evaluate responses to the interventions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to give informed consent
  • Overweight, defined as BMI 25-30 kg/m2
  • Modest hypertriglyceridemia, defined as fasting plasma triglycerides 1.5-3.0 mM
  • High risk of insulin resistance, defined as fasting plasma insulin >64 pM
  • Stable weight for at least 3 months prior to participation
  • Age between 18 and 65 years
Not Eligible

You will not qualify if you...

  • Active or chronic liver disease, kidney disease, congestive heart failure, unstable angina, history of acute cardiovascular events within 6 months 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 60 days prior to participation
  • Hematocrit less than 35%
  • Pregnancy or breastfeeding
  • Active tobacco use, excessive alcohol intake (>14 units per week), or history of drug abuse

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Behavioral Intervention

Duration - Up to 8 weeks

Participants undergo two crossover interventions to assess de novo lipogenesis (DNL): one with a standardized dinner and one with premeal exercise followed by a standardized dinner. Glucose tolerance and insulin sensitivity evaluations occur prior to interventions.

2 study visits, each including ingestion of deuterated water prior to dinner and blood draw the following morning

Trial Site Locations

Total: 1 location

1

AMC Amsterdam

Amsterdam, Netherlands

Actively Recruiting

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Research Team

D

Daniel F Vatner, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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