Status:
ACTIVE_NOT_RECRUITING
Causal Mechanisms in Adolescent Arterial Stiffness
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Lipid Disorder
Dyslipidemias
Eligibility:
All Genders
11-21 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Aortic stiffness measured in adolescence or adulthood determines current hypertension, predicts future incidence of hypertension, and future atherosclerotic cardiovascular disease (ASCVD) events. Inte...
Eligibility Criteria
Inclusion
- 11-21 year old adolescents
- males and females
- all ethnicities and races
- fasting serum triglyceride levels over 130 and less than 500 mg/dL
- fasting low density lipoprotein cholesterol (LDL-C) less than 160mg/dL.
Exclusion
- known seizure disorder
- renal failure patients requiring renal replacement therapy like dialysis or renal transplant
- diabetes mellitus type 1 or 2
- congenital heart disease requiring surgical or catheterization intervention
- current pregnancy or planned pregnancy during the active study participation
- incarceration/institutionalized/wards of the state
- known metabolic disorders that require carnitine therapy
- 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
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04128969
Start Date
February 1 2020
End Date
August 31 2026
Last Update
December 10 2025
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030