Needed: Teens with Non-alcoholic Steatohepatitis (NASH) who are Participating in the Surgical Weight Loss Program

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to find out if severely obese teens with non-alcoholic steatohepatitis (NASH) have more improvement with their NASH when they have weight loss surgery (WLS) or when they participate in a comprehensive lifestyle intervention (CLI).
We also want to test whether imaging studies and blood tests can be used to monitor the improvement in NASH after treatment (currently only a liver biopsy can do this).

Who can participate?

 Severely obese teens, 13 to 19 years old, who:

    • Have a diagnosis of NASH (confirmed by a liver biopsy within the last 90 days) 
    • Are participating in the Surgical Weight Loss Program for Teens at Cincinnati Children’s 

Those who have poorly controlled diabetes or cirrhosis, are taking more than 400 international units (IUs) of Vitamin E a day, or have had prior weight loss surgery, will not be able to take part in this study.

 

Ages

  • From 13 to 19 years old

Conditions

  • Gastroenterology - Digestive Tract - Stomach - Liver
  • Weight - Nutrition

What will happen in the study?

 There are two groups for this study: a clinical weight loss surgery (WLS) group and a comprehensive lifestyle intervention (CLI) group. You (if you are a participant who is 18 or older) or your teen will not be randomly chosen to participate in either of these groups. You or your teen have chosen to pursue clinical WLS and are eligible to participate in the WLS group.

These are the things that will happen while in the WLS study group: 

    • Measurements of blood pressure, heart rate, temperature, respiratory rate, height, weight, waist and hips 
    • Completion of surveys about alcohol use, liver symptoms and quality of life 
    • Physical exam 
    • Review of health, medical and medication history
    • Review of diet/food eaten within the last 24 hours
    • Blood draw for laboratory tests
    • MRI at the beginning and end of the study
    • 400-meter walk test
    • Liver biopsy for research

If you or your teen qualifies for this study, and you agree to participate, you will come to Cincinnati Children’s for 5 study visits over the next year. Whenever possible, visits will occur on the same day as routine clinical visits required for the Surgical Weight Loss Program for Teens.

You or your teen will have the option to pursue the CLI side of the study if you are not eligible for clinical weight loss surgery (e.g. lack of insurance coverage), and therefore the WLS research group. Or, you or your teen may choose to discontinue participation in the study.

After the clinical weight loss surgery, performed by the surgical team, you or your teen will complete the 4 remaining research study visits for follow-up medical history, anthropometric and laboratory measurements. We will provide you or your teen with a FitBit activity monitor and ask that you wear it throughout the study.

You or your teen will have a liver biopsy after being in the research study for 52 weeks. The biopsy will be used to determine if improvement in NASH was more common in those participants who had WLS compared to those who were treated with the CLI. Also, we may learn more about NASH in children and teens.
Participants, parents or guardians interested in having their teen participate 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 teen may or may not receive any direct benefit from participating in this study. However, you or your teen may receive potential benefits resulting from health information obtained during the physical exams, laboratory tests and other study procedures. You or your teen will also receive feedback on your physical activity through the use of the FitBit activity monitor.

We still have a lot to learn about whether WLS or CLI will lead to improvement in NASH and whether one will be more effective than the other. We hope that these treatments will help to reduce you or your teen’s NASH, but we do not know if they will. When we finish the research, we expect that we will know more about how NASH responds to WLS treatment. This may help other children and teens with NASH later on.

Will I get all the facts about the study?

You as a participant, or as a parent interested in having your teen 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 teen has given at minimum his/her verbal agreement.

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

Participants will receive a FitBit and up to $500 for completing all study-related visits and procedures.

Contact

Contact Us.Kimberlee Bernstein
kimberlee.bernstein@cchmc.org
513-636-4406
Cincinnati Children’s Hospital Medical Center
Gastroenterology, Hepatology, & Nutrition
3333 Burnet Avenue
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Stavra Xanthakos, MD, MS
Pediatric Gastroenterologist
Co-Director, Steatohepatitis Center 
Medical Director, Surgical Weight Loss Program for Teens
Cincinnati Children’s Hospital Medical Center