RECRUITING

Causal Mechanisms in Adolescent Arterial Stiffness

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Causal Mechanisms in Adolescent Arterial Stiffness

Quick Facts

Study Start:2020-02-01
Study Completion:2025-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04128969

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 11-21 year old adolescents
  2. 2. males and females
  3. 3. all ethnicities and races
  4. 4. fasting serum triglyceride levels over 130 and less than 500 mg/dL
  5. 5. fasting low density lipoprotein cholesterol (LDL-C) less than 160mg/dL.
  1. 1. known seizure disorder
  2. 2. renal failure patients requiring renal replacement therapy like dialysis or renal transplant
  3. 3. diabetes mellitus type 1 or 2
  4. 4. congenital heart disease requiring surgical or catheterization intervention
  5. 5. current pregnancy or planned pregnancy during the active study participation
  6. 6. incarceration/institutionalized/wards of the state
  7. 7. known metabolic disorders that require carnitine therapy
  8. 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

Contacts and Locations

Study Contact

Sandra Pena, CCRP
CONTACT
832-826-2806
sypena@texaschildrens.org
David Garuba
CONTACT
832-826-5925
garuba@bcm.edu

Principal Investigator

Justin P Zachariah, MD MPH
PRINCIPAL_INVESTIGATOR
Study Principal Investigator

Study Locations (Sites)

Texas Children's Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Justin P Zachariah, MD MPH, PRINCIPAL_INVESTIGATOR, Study Principal Investigator

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-01
Study Completion Date2025-08-30

Study Record Updates

Study Start Date2020-02-01
Study Completion Date2025-08-30

Terms related to this study

Keywords Provided by Researchers

  • dyslipidemia
  • arterial stiffness
  • pediatric obesity
  • metabolic syndrome
  • insulin resistance

Additional Relevant MeSH Terms

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