Metabolic Syndrome Clinical Trial
Official title:
Causal Mechanisms in Adolescent Arterial Stiffness
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 | Recruiting |
Enrollment | 90 |
Est. completion date | August 30, 2025 |
Est. primary completion date | May 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 11 Years to 21 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Carotid Femoral Pulse Wave Velocity | Carotid Femoral Pulse Wave Velocity will be measured noninvasively using applanation tonometry. | 6 months | |
Secondary | Change in Fasting Triglyceride | Fasting serum triglycerides to be measured using conventional techniques. | 6 months | |
Secondary | Change in Insulin Resistance | Insulin resistance will be assessed using fasting serum glucose and fasting serum insulin to calculate homeostatic model assessment of insulin resistance. | 6 month |
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