Metabolic Heterogeneity Underlying Hypertriglyceridemia: Hepatic Triglyceride Biosynthesis in Humans With Different Insulin Resistance Phenotypes
NCT ID: NCT05743868
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-11-16
2026-06-30
Brief Summary
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Detailed Description
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With this study, the investigators will demonstrate that the mechanisms that drive triglyceride overproduction in insulin-resistant humans are dependent on which tissues are insulin resistant. To this end, investigators will determine whether subjects with muscle insulin resistance and adipose tissue insulin resistance utilize different mechanisms of triglyceride biosynthesis to assemble hepatic very low density lipoprotein (VLDL), as compared with individuals with muscle insulin resistance but relative adipose tissue insulin sensitivity. Additionally, investigators will see if adipose tissue insulin sensitivity predicts exercise responsiveness of hepatic triglyceride production.
Main study parameters/endpoints: Difference in %DNL between subjects with global vs muscle-only insulin resistance as well as the differential effects of premeal exercise on %DNL in these groups.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Randomized crossover within group design.
BASIC_SCIENCE
NONE
Study Groups
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IR participants with standardized dinner
Participants with global IR and tissue-specific IR. Participants with global IR (in both skeletal muscle and adipose tissue) and tissue-specific IR (in adipose tissue). Glucose tolerance, skeletal muscle/whole-body insulin sensitivity and adipose tissue insulin sensitivity will be evaluated prior to intervention.
Contribution of DNL to hepatic VLDL will be measured using a deuterated water drink, to be ingested prior to the standardized dinner. Blood will be drawn the following morning for the measurement of deuterium incorporation into triglycerides. Plasma deuterium will be allowed to wash out over several weeks, and the 2nd deuterated water study will be performed.
Standardized Dinner
De novo lipogenesis (DNL) will be assessed in all participants with a standardized dinner
IR participants with standardized dinner and premeal exercise
Participants with global IR and tissue-specific IR. Participants with global IR (in both skeletal muscle and adipose tissue) and tissue-specific IR (in adipose tissue). Glucose tolerance, skeletal muscle/whole-body insulin sensitivity and adipose tissue insulin sensitivity will be evaluated prior to intervention.
DNL will be assessed in all participants after a single day with short bouts of premeal exercise with a standardized dinner.
Contribution of DNL to hepatic VLDL will be measured using a deuterated water drink, to be ingested prior to the standardized dinner. Blood will be drawn the following morning for the measurement of deuterium incorporation into triglycerides. Plasma deuterium will be allowed to wash out over several weeks, and the 2nd deuterated water study will be performed.
Standardized Dinner
De novo lipogenesis (DNL) will be assessed in all participants with a standardized dinner
Premeal exercise
DNL will be assessed in all participants with short bouts of premeal exercise with a standardized dinner
Interventions
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Standardized Dinner
De novo lipogenesis (DNL) will be assessed in all participants with a standardized dinner
Premeal exercise
DNL will be assessed in all participants with short bouts of premeal exercise with a standardized dinner
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Amsterdam UMC
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Daniel F Vatner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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AMC Amsterdam
Amsterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Vatner 012523
Identifier Type: -
Identifier Source: org_study_id
NL83166.018.22
Identifier Type: OTHER
Identifier Source: secondary_id
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