Actively Recruiting
Liver Adiposity Effects on Pediatric Statin
Led by Children's Mercy Hospital Kansas City · Updated on 2025-11-26
50
Participants Needed
1
Research Sites
300 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 and adolescents 8-21 years of age with normal, wild-type SLCO1B1 c.521TT genotype that are dosed rosuvastatin
CONDITIONS
Official Title
Liver Adiposity Effects on Pediatric Statin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 8 to 21 years
- LDL cholesterol greater than 130 mg/dl (above the 95th percentile)
- SLCO1B1 c.521TT genotype
- Provide informed permission-assent if under 18 years or consent if 18 years or older
- Fasting overnight for about 8 hours before study visits
- Enrolled in the Cardiology Pharmacogenomic Repository
You will not qualify if you...
- Pregnancy
- Not fasting before study visits
- Presence of non-removable metal in the body or any condition unsafe for MRI
- Currently on statin therapy and unwilling to stop it for at least 4 weeks before Visit 1 and during the study
- Unrepaired or repaired congenital or acquired cardiovascular defects with significant residual disease
- History or lab evidence of intestinal, metabolic, autoimmune, or renal disease affecting rosuvastatin processing
- Use of medications that interact with statins (OATP1B1 inducers or inhibitors)
- Inability to swallow a tablet
- Liver enzyme levels (AST, ALT), bilirubin levels greater than 5 times the age-specific upper limit
- Diarrhea in the last 24 hours
- Conditions preventing MRI completion such as pacemakers, claustrophobia, or weight over 350 lbs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
Research Team
J
Jonathan Wagner, DO
CONTACT
J
Jazzie K Holliday
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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