Clinical Trials / Research Studies
A Study to Compare Medical vs. Surgical Treatment in Children and Teens With Type 2 Diabetes
Why are we doing this research?
Cincinnati Children's is conducting a research study, sometimes known as a clinical trial or clinical study, to compare blood sugar control between two groups: teens who undergo weight loss (bariatric) surgery and teens who are being treated with only medications. We will also be looking at how well the body makes and uses insulin, cholesterol levels, blood pressure, kidney function, and liver health over time.Who can participate?
Teens and young adults, 13 to 19.9 years old, with type 2 diabetes may be eligible to participate.Conditions
- Diabetes
What will happen in the study?
This study will last for a period of 2.5 years. You will be asked to come for your usual diabetes clinic visits every 3 months and participate in 3 study visits lasting 8 hours.
Participants will:
- Have blood draws with an IV placed
- Have height, weight, waist, hip, and blood pressure measurements
- Complete a liver MRI
- Wear an activity and sleep monitor
- Wear a continuous glucose monitor (CGM)
- Complete a food diary
- Complete questionnaires
Young adults or parents 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 not have a direct medical benefit. However, the information we obtain from this study may help us to learn if optimal blood sugar control can be achieved in those with type 2 diabetes with medications only vs. weight loss (bariatric) surgery.What are the bad things that can happen from this research?
There is very little risk to participants in this research study. We will discuss possible risks and discomforts with parents or guardians interested in learning more about the study.Will you/your child be paid to be in this research study?
Participants will receive up to $1,150 for their time and effort.
Study Doctor
Amy Sanghavi Shah, MD, MSPediatric Endocrinology
Director, Adolescent Type 2 Diabetes Program
Cincinnati Children’s Hospital Medical Center
3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
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