Clinical Trials

Teens with Nonalcoholic Fatty Liver Disease (NAFLD) Needed for a Research Study

Why are we doing this research?

The human body, particularly the liver, has the ability to change and breakdown medications. 

We want to find out if people who have Nonalcoholic Fatty Liver Disease (NAFLD) change and breakdown medications differently than people who do not have NAFLD.

Who can participate?

Teens, 12 to 18 years old, who have a clinical diagnosis of NAFLD (confirmed by a liver biopsy within the last 12 months) are eligible for participation.


What will happen in the study?

If you (if you are 18) or your child qualifies for this study, and you agree to participate, you will come to Cincinnati Children’s for 2 study visits.

The first visit will be a screening visit. At this visit, the study will be explained to you and/or your child and a sample of saliva will be collected.

If you or your child qualifies for the study after the first visit, or screening, you will have a second visit. This visit will last about 6 hours. 

You or your child will be asked to fast (not eat or drink anything, except water, from at least midnight on) the night and morning before the second study visit.

During the second study visit, you or your child will be asked to give samples and complete tests and procedures, including:

  • Pregnancy test (if applicable)
  • Blood draws/samples
  • Urine samples

You or your child will also be given a mixture of 4 drugs in small doses to take by mouth with water:  caffeine (about the same dose as 2 cans of cola), omeprazole (also called Prilosec or Zegerid), losartan (Cozaar, Hyzaar) and midazolam (Versed).

You or your child will be permitted to eat and drink once the medications have been administered, with the exception of caffeine, charbroiled foods, broccoli and grapefruit or grapefruit juice.  Food and drink will be provided for you or your child.

A detailed list of procedures will be provided to anyone interested in learning more about this study.

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

You or your child may not receive any direct benefit from participating in this study. However, the information learned from this study may help other people with NAFLD or Nonalcoholic steatohepatitis (NASH) in the future.  

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

A detailed list of possible side effects will be provided to those participants, parents or guardians interested in knowing more about this study. 

Will I get all the facts about the study?

You as a participant, or as a parent interested in having your child participate, will be given a consent form that thoroughly explains all of the details of the study.  The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns, and more.  A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.  Study procedures will not begin until a parent or guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.

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

Participants will receive a $100 gift card for their time and travel after completing the 2 study visits. 

Who should I contact for more information?

Kimberlee Bernstein

513-636-4406

Kimberlee.bernstein@cchmc.org

Cincinnati Children’s Hospital Medical Center

Gastroenterology, Hepatology, & Nutrition

3333 Burnet Avenue

Cincinnati, OH  45229-3039

Study Doctor:

Stavra Xanthakos, MD, MS

Pediatric Gastroenterologist

Co-Director, Steatohepatitis Center

Medical Director, Surgical Weight Loss Program for Teens

Cincinnati Children’s Hospital Medical Center