Do It! Study
We are doing this research study to find out if a drug that lowers cholesterol, called pitavastatin, can help lower cholesterol in children and teens who are obese with high cholesterol. This condition of obesity with high cholesterol is sometimes called “Combined Dyslipidemia of Obesity” or CDO. When people have CDO for many years, it can cause their arteries to harden and narrow (called atherosclerosis). This can then lead to serious health problems including heart attack, stroke, or even death.
Pitavastatin is commonly known as Livalo and belongs to a group of cholesterol lowering medicines called statins. It is approved by the Food and Drug Administration (FDA) and Health Canada for use in adults and in children with another type of high cholesterol. It lowers blood total cholesterol as well as “bad” cholesterol (called LDL) that raises the risk of heart disease and heart attacks. It also increases the “good” type of cholesterol (called HDL).
Who can be in the study?
Male or females between the age of 10 and 17 who have Combined Dyslipidemia of Obesity (CDO)
What do we have to do to be in the study?
The study will be explained to you in detail by one of the study investigators. Once your questions have been answered, you will be asked to sign an informed consent form/Assent form to enter the study.This is what needs to be done in the study:
- Medical History: We will review your medical chart and collect information about surgeries and medical procedures.
- Physical Examination: Weight and height measurements, blood pressure, head circumference and waist circumference.
- Blood Draw: Draw a blood sample while fasting to check lab values, take DNA samples and extra blood to be saved for future study.
- Pregnancy Test: for female subjects.
- Tanner Staging Report: Questionnaire that asks about physical maturity and development.
- Three Vascular Measurements: Pulse Wave Velocity, Carotid Intima-Media Thickness Carotid Stiffness test will be conducted to see how blood vessels function.
How long will we be in the study?
If your child qualifies for this study, it will take 24 months for him/her to complete their participation in this research study.
What are the possible benefits to being in this study?
Your child may not benefit from taking part in this research study. But the information we learn from this study may help improve the care of other children.
What are the possible risks to being in this study?
- As with any drug, an allergic reaction can occur.
- There are restrictions for several medications while your child is in the study. The study doctor and a member of the research team will review your child’s medication history throughout study participation.
- The effect of Pitavastatin on an embryo or fetus (developing baby still in the womb) is unknown and may be harmful. Because of these unknown risks, women cannot take part in this study if they are pregnant or trying to become pregnant.
- Risks associated with drawing blood from a vein include momentary discomfort and/or bruising. Infection, excess bleeding, clotting, and fainting are also possible, although very unlikely. Applying a numbing cream to the skin may be helpful in to lessen the discomfort of a blood draw.
- There are no risks associated with physical examination.
- Your child may experience minor skin irritation from the sticky patches placed on his/her skin for the vascular testing and he/she may experience minimal discomfort as a result of pressure on the chest from the sensor during the procedure.
- There may be some inconvenience of completing the study visits and some children may feel uncomfortable completing the Tanner Staging form or answering questions. There is a small chance that participation in this study could cause psychological distress.
- There may be risks to being in this study that we don't know about now.
What are the costs to me to be in the study?
There will be no extra costs to you when you join this study. You must pay for all other costs related to your normal medical care such as hospital stays, surgery, drugs, lab tests, and doctor's fees which are thought to be standard medical care for patients with your condition.