Clinical Trial

Causal Mechanisms in Adolescent Arterial Stiffness

Active, Not Recruiting Phase 2
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Record status
This record was last updated December 10, 2025 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2019-10-14; most recent amendment 2025-12-04.
Status change: Recruiting → Active, Not Recruiting 2025-12-04
Status change: Not Yet Recruiting → Recruiting 2020-01-13
Trial Details
NCT Number NCT04128969
Lead Sponsor Baylor College of Medicine
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Lipid Disorder, Dyslipidemias, Aortic Stiffness, Insulin Resistance Syndrome, Metabolic Syndrome, Pediatric Obesity
Enrollment 90 participants
Start Date 2020-02-01
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-10