Teens with Nonalcoholic Fatty Liver Disease (NAFLD) Needed for a Research Study
Why are we doing this research?
human body, particularly the liver, has the ability to change and breakdown
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?
will receive a $100 gift card for their time and travel after completing the 2
Who should I contact for more information?
Children’s Hospital Medical Center
Hepatology, & Nutrition
3333 Burnet Avenue
Cincinnati, OH 45229-3039
Xanthakos, MD, MS
Director, Surgical Weight Loss Program for Teens
Children’s Hospital Medical Center