Causal Mechanisms in Adolescent Arterial Stiffness

Launched by BAYLOR COLLEGE OF MEDICINE · Oct 14, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a condition called arterial stiffness, which is when blood vessels become hard and can lead to heart disease later in life. The researchers want to find out if a protein supplement called carnitine can help prevent this stiffening in adolescents who are at high risk. They will also look at how certain genes related to carnitine might affect arterial stiffness. The trial aims to understand the role of carnitine in this process and could lead to new ways to treat or prevent arterial stiffness.

To participate in the study, adolescents aged 11 to 21, both boys and girls from all backgrounds, may be eligible if they have certain levels of fat in their blood. However, some individuals, such as those with diabetes, severe kidney issues, or specific heart conditions, cannot join the study. Participants can expect to take a supplement and be monitored for any changes in their blood vessels over time. This research is important because it could provide insights into preventing heart problems in young people.

Gender

ALL

Eligibility criteria

• 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