Status:
RECRUITING
Liver Adiposity Effects on Pediatric Statin
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Cholesterol; Lipidosis
Eligibility:
All Genders
8-21 years
Phase:
PHASE1
Brief Summary
Single center, open-label, prospective investigation to quantify the effects hepatocellular fat has on hepatic statin transport and response in children and adolescents in obese and non-obese children...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04903223
Start Date
April 1 2021
End Date
December 31 2026
Last Update
November 26 2025
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108