Dyslipidemia of Obesity Intervention in Teens: DO-IT Study – Phase IV

Protocol Description

The purpose of this multi-center study is to determine if a medicine used to lower cholesterol, pitavastatin, can improve artery health in adolescents and teens with combined dyslipidemia of obesity (CDO). CDO is a medical condition in which overweight/obese people have high blood lipids (cholesterol and fats). When people have CDO for many years, the lipids may build up in the arteries causing them to become thick, narrow, and stiff. This buildup of lipids can lead to serious health problems including heart attack, stroke, or even death.

Study Level: Phase IV

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling participants of both genders, ages 10 through 17, who have CDO.
Males and Females: Ages 10 through 17

Requirements

Participants will take a pill, either pitavastatin or placebo, once daily for 2 years and will be seen by the research team 9 times at Children’s Hospital of Pittsburgh of UPMC. During visits, participants will receive physical examinations including body measurements, ultrasound tests to measure thickness and stiffness of blood vessels, and blood draws. The study staff will also provide counseling on healthy nutrition and exercise.
Visits: 9
Duration: 2 years

Status: Open to Enrollment

Source(s) of Support

Pediatric Heart Network of the National Heart, Lung, and Blood Institute of the National Institutes of Health
New England Research Institutes (coordinating center)

Primary Investigator

Silva Arslanian, MD

Contact Information

For more information about the study or enrollment, please contact:
DO-IT study coordinator Samantha Cochenour, RN
412-692-6635