NCT04128969CompletedPhase 2
Causal Mechanisms in Adolescent Arterial Stiffness
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 11 Oct 2019
- Start date
- 1 Feb 2020
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Baylor College of Medicine
- Diseases
- Obesity
- NCT number
- NCT04128969
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 72
- From 1 Feb 2020 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- known metabolic disorders that require carnitine therapy
Other
- current pregnancy or planned pregnancy during the active study participation
- incarceration/institutionalized/wards of the state
- 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
Who the study is looking for
- 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.
Age in the registry: 11 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texas Children's Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.