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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Rosuvastatin 10mg
DrugRosuvastatin will be administered to all participants on Study Day #2
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Baseline Mevalonate and MRI ImagingNo intervention 0 interventions
Group B: Mevalonate Change After RosuvastatinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate effect of Liver Fat Percentage (on MRI) on AUC
We expect that increased liver adiposity will be associated with higher systemic statin exposure and thus, place those with higher liver adiposity fraction at increased risk for drug toxicity.
Time frame
2 years2
Evaluate effect of Liver Fat Percentage (on MRI) on change on plasma mevalonate level
We expect that increased liver adiposity will be associated with an attenuated mevalonate response to a statin in obese children placing those with increased liver adiposity at risk for treatment failure.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov