Causal Mechanisms in Adolescent Arterial Stiffness

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

Causal Mechanisms in Adolescent Arterial Stiffness

Causal Mechanisms in Adolescent Arterial Stiffness

Condition
Lipid Disorder
Intervention / Treatment

-

Contacts and Locations

Houston

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 11-21 year old adolescents
  • 2. males and females
  • 3. all ethnicities and races
  • 4. fasting serum triglyceride levels over 130 and less than 500 mg/dL
  • 5. fasting low density lipoprotein cholesterol (LDL-C) less than 160mg/dL.
  • 1. known seizure disorder
  • 2. renal failure patients requiring renal replacement therapy like dialysis or renal transplant
  • 3. diabetes mellitus type 1 or 2
  • 4. congenital heart disease requiring surgical or catheterization intervention
  • 5. current pregnancy or planned pregnancy during the active study participation
  • 6. incarceration/institutionalized/wards of the state
  • 7. known metabolic disorders that require carnitine therapy
  • 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

Ages Eligible for Study

11 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Baylor College of Medicine,

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

Study Record Dates

2025-08-30