Causal Mechanisms in Adolescent Arterial Stiffness
United States90 participantsStarted 2020-02-01
Plain-language summary
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.
Who can participate
Age range11 Years – 21 Years
SexALL
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Inclusion criteria
✓. 11-21 year old adolescents
✓. males and females
✓. all ethnicities and races
✓. fasting serum triglyceride levels over 130 and less than 500 mg/dL
✓. fasting low density lipoprotein cholesterol (LDL-C) less than 160mg/dL.
Exclusion criteria
✕. known seizure disorder
✕. renal failure patients requiring renal replacement therapy like dialysis or renal transplant
✕. diabetes mellitus type 1 or 2
✕. congenital heart disease requiring surgical or catheterization intervention
✕. current pregnancy or planned pregnancy during the active study participation
✕. incarceration/institutionalized/wards of the state
✕. known metabolic disorders that require carnitine therapy
✕. 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