Effects of carnitine on arterial stiffness in adolescents
Causal Mechanisms in Adolescent Arterial Stiffness
PHASE2 · Baylor College of Medicine · NCT04128969
This study is testing if taking carnitine can help reduce arterial stiffness in teenagers aged 11-21 who have high triglyceride levels.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 11 Years to 21 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04128969 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of carnitine supplementation on arterial stiffness in adolescents aged 11-21 who are at high risk due to elevated triglyceride levels. Participants will be randomly assigned to receive either carnitine or a placebo for six months, with arterial stiffness measured through carotid femoral pulse wave velocity. The study aims to clarify the causal relationship between carnitine levels and arterial stiffness, potentially linking it to insulin resistance and metabolic health. Additionally, genetic factors related to carnitine metabolism will be explored to understand their influence on arterial stiffness.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 11-21 with fasting triglyceride levels between 130 and 500 mg/dL and LDL-C levels below 160 mg/dL.
Not a fit: Patients with diabetes, known metabolic disorders requiring carnitine therapy, or severe renal issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel approach to prevent arterial stiffness and associated cardiovascular risks in adolescents.
How similar studies have performed: While the specific approach of using carnitine for arterial stiffness in adolescents is novel, preliminary data suggest potential benefits from carnitine related to metabolic health.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- Texas Children's Hospital — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Justin P Zachariah, MD MPH — Study Principal Investigator
- Study coordinator: Sandra Pena, CCRP
- Email: sypena@texaschildrens.org
- Phone: 832-826-2806
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: Lipid Disorder, Dyslipidemias, Aortic Stiffness, Insulin Resistance Syndrome, Metabolic Syndrome, Pediatric Obesity, dyslipidemia, arterial stiffness