14 to 25 Year Old Males Who Have Type 2 Diabetes Needed for a Cholesterol and Heart Disease Research Study

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study to learn about the effects of cholesterol, both good and bad, on heart disease. 

We also want to look at blood cholesterol and compare it between teens that have type 2 diabetes, teens that are obese and teens that are normal weight.

Who can participate?

Male teens and adults, 14 to 25 years old, who have type 2 diabetes, may be eligible for participation.

Those who smoke or take medications for cholesterol will NOT be able to participate.

Conditions

  • Diabetes - Endocrinology - Metabolism

What will happen in the study?

If you (for participants 18 years or older) or your child qualifies for this study, and you decide to participate, you will come to Cincinnati Children’s for 1 study visit.

These are the things that may happen at the study visit:

  • Health assessment to measure height, weight and blood pressure
  • Blood samples
  • Blood vessel testing

Prior to taking the blood samples, we will ask that you or your child do not have anything to eat or drink (other than water) for 8 to 10 hours before the study visit. The blood samples will be used to measure cholesterol and possibly blood sugar/blood sugar control over the past 3 months.

You or your child may also have blood vessel testing performed, which involves 2 procedures: a SphygmoCor test and an ultrasound.

During the SphygmoCor test, a study staff member will take some body measurements, including the distance from the neck to the bottom of the sternum (breast bone) and from the sternum to the wrist. Then, electrode pads will be placed on you or your child’s chest and you will be touched with a small instrument shaped like a pen. The instrument (which does not use not use radiation/X-rays, sound waves/ultrasound, or needles) will measure the stiffness of the blood vessels.

You or your child will also have an ultrasound (echocardiogram) of your carotid arteries while lying down. Gel will be applied to the neck and then an ultrasound probe will be placed there to take pictures of the arteries. 

You, as a participant or as a parent/guardian, will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.

What are the good things that can happen from this research?

You or your child will not receive a direct benefit from participating in this research study. The information learned from this research study may benefit other patients with high or low blood cholesterol levels in the future.

What are the bad things that can happen from this research?

There are minimal risks associated with this research study. Possible risks and side effects will be provided to and discussed with those participants, parents or guardians interested in knowing more about this study.

Will you/your child be paid to be in this research study?

Participants may receive up to $125 for their time and travel.

Contact

Contact Us.Study Coordinator
HDL2@cchmc.org
513-803-0366
Cincinnati Children’s Hospital Medical Center
3333 Burnet Avenue
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Amy Shah, MD
Cincinnati Children’s Hospital Medical Center
Division of Endocrinology