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Teen artery stiffness study tests carnitine supplement for heart health

NCT ID NCT04128969

Disease control Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a protein supplement called carnitine can reduce hardening of the arteries in teenagers at high risk for future heart disease. About 90 teens aged 11-21 with high triglycerides will take carnitine or a placebo. Researchers will measure artery stiffness and check for changes in blood fats and insulin resistance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2020

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

11 to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 11-21 year old adolescents 2. males and females 3. all ethnicities and races 4. fasting serum triglyceride levels over 130 and less than 500 mg/dL 5. fasting low density lipoprotein cholesterol (LDL-C) less than 160mg/dL. Exclusion Criteria: 1. known seizure disorder 2. renal failure patients requiring renal replacement therapy like dialysis or renal transplant 3. diabetes mellitus type 1 or 2 4. congenital heart disease requiring surgical or catheterization intervention 5. current pregnancy or planned pregnancy during the active study participation 6. incarceration/institutionalized/wards of the state 7. known metabolic disorders that require carnitine therapy 8. nonadherence to study protocol during run-in phase defined as possessing 25% more than the expected remainder of placebo supplement pro-rated to the day of assessment

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome Dyslipidemias hyperlipidemia hypertriglyceridemia inherited lipid metabolism disorder Insulin Resistance Lipid Metabolism Disorders metabolic syndrome X obesity disorder Pediatric Obesity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stiffness Dyslipidemias Insulin resistance syndrome Lipid disorder Metabolic syndrome Pediatric obesity

Contacts and locations

Locations

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.