RECRUITING

Liver Adiposity Effects on Pediatric Statin

Talk to us

Conditions

Cholesterol; Lipidosis

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

Effects of Pediatric Liver Adiposity on Statin Disposition and Response

Quick Facts

Study Start:2021-04-01
Study Completion:2025-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04903223

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.

Ages Eligible for Study:8 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 8-21 years
  2. * LDL cholesterol \>130mg/dl (\>95% percentile)
  3. * SLCO1B1 c.521TT genotype
  4. * Provide informed permission-assent(\<18 yrs.) or consent (≥18 yrs.)
  5. * Fasting overnight (\~8 hrs.)
  6. * Enrolled in Cardiology Pharmacogenomic Repository
  1. * Pregnancy
  2. * Non-fasting
  3. * Non-removable metal in body or MRI unsafe
  4. * 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.
  5. * Underlying unrepaired congenital or acquired cardiovascular defects or repaired congenital or acquired cardiovascular defects with hemodynamically significant residual disease.
  6. * History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter rosuvastatin disposition\* (absorption, metabolism, distribution, or clearance)
  7. * Pharmacotherapy that interacts with statins (OATP1B1 inducers/inhibitors) \*
  8. * Inability to swallow a tablet
  9. * \>5x the age-specific upper limit of normal for AST, ALT, total and conjugated bilirubin
  10. * Diarrhea in the last 24 hours
  11. * Anything that would exclude a participant from completing an MRI, such as pacemakers, claustrophobia, or body habitus (e.g., weight greater than 350 lbs.)

Contacts and Locations

Study Contact

Jonathan Wagner, DO
CONTACT
816-731-7240
jbwagner@cmh.edu
Jazzie K Holliday
CONTACT
816-302-3500
jkholliday@cmh.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Children's Mercy Hospital Kansas City

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-01
Study Completion Date2025-01-30

Study Record Updates

Study Start Date2021-04-01
Study Completion Date2025-01-30

Terms related to this study

Additional Relevant MeSH Terms

  • Cholesterol; Lipidosis