Effects of liver fat on statin response in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates how hepatocellular fat influences the transport and effectiveness of the statin rosuvastatin in children and adolescents aged 8-21 years. It focuses on both obese and non-obese participants with elevated LDL cholesterol levels and a specific genetic profile (SLCO1B1 c.521TT). The study is conducted at a single center and aims to quantify the relationship between liver fat and statin response, providing insights into personalized treatment approaches for pediatric patients. Participants will receive a 10mg dose of rosuvastatin after meeting specific eligibility criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 8-21 years
* LDL cholesterol \>130mg/dl (\>95% percentile)
* SLCO1B1 c.521TT genotype
* Provide informed permission-assent(\<18 yrs.) or consent (≥18 yrs.)
* Fasting overnight (\~8 hrs.)
* Enrolled in Cardiology Pharmacogenomic Repository

Exclusion Criteria:

* Pregnancy
* Non-fasting
* Non-removable metal in body or MRI unsafe
* Currently on statin therapy and unwilling to wash out of statin therapy for at least 4 weeks prior to Visit 1 and throughout the duration of the study.
* Underlying unrepaired congenital or acquired cardiovascular defects or repaired congenital or acquired cardiovascular defects with hemodynamically significant residual disease.
* History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter rosuvastatin disposition\* (absorption, metabolism, distribution, or clearance)
* Pharmacotherapy that interacts with statins (OATP1B1 inducers/inhibitors) \*
* Inability to swallow a tablet
* \>5x the age-specific upper limit of normal for AST, ALT, total and conjugated bilirubin
* Diarrhea in the last 24 hours
* Anything that would exclude a participant from completing an MRI, such as pacemakers, claustrophobia, or body habitus (e.g., weight greater than 350 lbs.)

Where it's running

• Children's Mercy Hospital
  Kansas City, Missouri, United States Recruiting

Study contacts

• Study coordinator: Jonathan Wagner, DO
• Email: jbwagner@cmh.edu
• Phone: 816-731-7240

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.