Liver Adiposity Effects on Pediatric Statin
ConditionCholesterol; Lipidosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age8-21
SponsorChildren's Mercy Hospital Kansas City
About this trial
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
Eligibility criteria
Qualifiers
8-21 years
LDL cholesterol >130mg/dl (>95% percentile)
SLCO1B1 c.521TT genotype
Provide informed permission-assent(<18 yrs.) or consent (≥18 yrs.)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Rosuvastatin 10mg
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov