Liver Adiposity Effects on Pediatric Statin
Recruiting · NCT04903223 · Interventional (participants receive a specific treatment) · Lead sponsor: Children's Mercy Hospital Kansas City
View the official record on ClinicalTrials.gov →Interventions studied
Rosuvastatin 10mg
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
Who can take part
Age range
8 Years to 21 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- Children's Mercy Hospital - Kansas City, Missouri, United States