Liver Adiposity Effects on Pediatric Statin
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
| Condition(s) | Cholesterol; Lipidosis |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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 and adolescents 8-21 years of age with normal, wild-type SLCO1B1 c.521TT genotype that are dosed rosuvastatin |
| Who can participate | 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 c |
| Ages | 8 Years to 21 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Children's Mercy Hospital Kansas City |
| Locations | Kansas City, Missouri, United States |
| Start date | 2021-04-01 |
| NCT ID | NCT04903223 |
| Official listing | https://clinicaltrials.gov/study/NCT04903223 |