Liver Adiposity Effects on Pediatric Statin

Description

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

Conditions

Cholesterol; Lipidosis

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Study Overview

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Study Details

Study overview

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

Effects of Pediatric Liver Adiposity on Statin Disposition and Response

Liver Adiposity Effects on Pediatric Statin

Condition
Cholesterol; Lipidosis
Intervention / Treatment

-

Contacts and Locations

Kansas City

Children's Mercy Hospital, Kansas City, Missouri, United States, 64108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.)

Ages Eligible for Study

8 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Children's Mercy Hospital Kansas City,

Study Record Dates

2025-01-30