Clinical trial

Causal Mechanisms in Adolescent Arterial Stiffness

Active, not recruiting · Phase 2 · 1 countries · Registry ID NCT04128969

Active, not recruitingPhase 2Interventional

What this study is about

Hardening of the blood vessels, called arterial stiffness, is a risk factor for future heart disease and its causes are unclear. The proposed study will 1) randomly assign adolescents at high risk of stiffening blood vessels to take a protein supplement called carnitine and study its effects on arterial stiffening and 2) study carnitine related genes for their effect on arterial stiffening. The study will definitively establish a role for carnitine action as a cause of stiffening blood vessels and signal a way to treat or prevent stiffening.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age11 Years to 21 Years

SexAll

Healthy volunteersNot accepted

ConditionLipid Disorder, Dyslipidemias, Aortic Stiffness, Insulin Resistance Syndrome, Metabolic Syndrome, Pediatric Obesity

Full registry 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

Treatments and study arms

CS+

Dietary Supplement

Oral carnitine supplementation

CS-

Dietary Supplement

Placebo

Primary outcomes

Change in Carotid Femoral Pulse Wave Velocity6 months

Carotid Femoral Pulse Wave Velocity will be measured noninvasively using applanation tonometry.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Texas Children's Hospital🇺🇸 Houston, Texas, United States

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