Causal Mechanisms in Adolescent Arterial Stiffness

RECRUITING

I'm interested ...!!

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

🗓️ Study Start (Actual) 1 February 2020

🗓️ Primary Completion (Estimated) 30 May 2025

✅ Study Completion (Estimated) 30 August 2025

👥 Enrollment (Estimated) 90

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE2

Locations:

📍 Houston, Texas, United States

📋 Eligibility Criteria

Description

Inclusion 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.

Exclusion Criteria:

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 (CHILD, ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ 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

First Submitted 11 October 2019
First Submitted that Met QC Criteria 14 October 2019
First Posted 16 October 2019

Study Record Updates

Last Update Submitted that Met QC Criteria 2 May 2024
Last Update Posted 3 May 2024
Last Verified May 2024