Causal Mechanisms in Adolescent Arterial Stiffness

NCT04128969 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: H-45557R01HL148217
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Carotid Femoral Pulse Wave Velocity

  Carotid Femoral Pulse Wave Velocity will be measured noninvasively using applanation tonometry.

  6 months

Secondary Outcomes (2)

• Change in Fasting Triglyceride

  6 months

• Change in Insulin Resistance

  6 month

Study Arms (2)

Carnitine supplementation (CS+)

EXPERIMENTAL

Carnitine supplementation in liquid form, sugar free.

Dietary Supplement: CS+

Placebo (CS-)

PLACEBO COMPARATOR

Placebo comparator liquid similar in appearance and taste to CS+.

Dietary Supplement: CS-

Interventions

CS- DIETARY_SUPPLEMENT

Placebo

Placebo (CS-)

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lipid Metabolism Disorders; Dyslipidemias; Metabolic Syndrome; Pediatric Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Justin P Zachariah, MD MPH

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Assistant Professor in Pediatrics

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 16, 2019
• Study Start: February 1, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)