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Causal Mechanisms in Adolescent Arterial Stiffness

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Primary completion date: May 30, 2025 to Jun 1, 2026 Trial status: Recruiting to Active, Not Recruiting · Completion date: Aug 30, 2025 to Aug 31, 2026 · Site details revisedv9 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Aug 30, 2025 to Aug 31, 2026
    • Site details revised
  2. Primary completion date: May 30, 2024 to May 30, 2025 Completion date: Aug 30, 2024 to Aug 30, 2025v8 Show 1 more changeShow less
    • Completion date: Aug 30, 2024 to Aug 30, 2025
  3. Enrollment target: 166 to 90 Eligibility criteria revised · Site contact updated · Study description expanded, about 3 wordsv7 Show 3 more changesShow less
    • Eligibility criteria revised
    • Site contact updated
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Phase: Early Phase 1 to Phase 2v6
  5. Phase: Phase 3 to Early Phase 1v5
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Start date changed from estimate of Jan 20, 2020 to Feb 1, 2020v3
  3. Trial status: Not Yet Recruiting to Recruiting Start date: Nov 2019 to Jan 20, 2020 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date: Nov 2019 to Jan 20, 2020
    • Study sites: 0 to 1
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov