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Causal Mechanisms in Adolescent Arterial Stiffness

NCT04128969 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-12-10

No results posted yet for this study

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.

Conditions

  • Lipid Disorder
  • Dyslipidemias
  • Aortic Stiffness
  • Insulin Resistance Syndrome
  • Metabolic Syndrome
  • Pediatric Obesity

Interventions

DIETARY_SUPPLEMENT

CS+

Oral carnitine supplementation

DIETARY_SUPPLEMENT

CS-

Placebo

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Justin P Zachariah, MD MPH · Study Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2026-06-01
Completion
2026-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04128969 on ClinicalTrials.gov