Trials Today

Liver Adiposity Effects on Pediatric Statin

Purpose

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

Cholesterol; Lipidosis

Eligibility

Eligible Ages: Between 8 Years and 21 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

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.)

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a single center, open-label, prospective, investigation to quantify the effects hepatocellular fat has on hepatic statin transport (SA1) and response (SA2) in children and adolescents.
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
No Intervention Baseline Mevalonate and MRI Imaging
Experimental Mevalonate Change After Rosuvastatin		Drug: Rosuvastatin 10mg Rosuvastatin will be administered to all participants on Study Day #2

Recruiting Locations

Children's Mercy Hospital
Kansas City, Missouri 64108

Contact:
Jonathan B Wagner, DO
816-234-3000
jbwagner@cmh.edu

More Details

NCT ID: NCT04903223
Status: Recruiting
Sponsor: Children's Mercy Hospital Kansas City

Study Contact

Jonathan Wagner, DO
816-731-7240
jbwagner@cmh.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.