Cardiovascular Disorders in Adolescents with Type 2 Diabetes
What is the purpose of the study?
People with type 2 diabetes have more heart disorders than those without diabetes. This research study will help researchers understand when heart and blood vessel problems occur and help other researchers in figuring out better ways to treat patients.
Who will be included in the study?
Volunteers ages 10 and 23 diagnosed with type 2 diabetes or without diabetes may be eligible to participate.
What is involved?
This study includes 2 visits and lasts approximately 2 weeks.
- Visit 1
- The participant will take part in several ultrasound test of the heart and blood vessels, have blood drawn, and complete a questionnaire. The visit will last approximately 3 to 4 hours.
- Between Visit 1 and 2
- The participant will keep a 3-day food and activity diary. In addition, the study participant will wear a small device on the waistband of their clothing for one week to measure activity levels.
- Visit 2
- This visit will last approximately 1 hour. The study participant will receive one additional test measuring body muscle and discuss the food and activity diary.
What are the benefits?
Your or your child may receive no direct benefit from participating in this study. The biggest benefit is that you and your child may be helping other children and adults. Clinical studies are essential in finding new and improved treatments and diagnostic tools.
Will I Get all the facts about the study?
Adult participants and parents who are interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. It includes all of the procedures, risks, benefits, compensation, 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 the parent/guardian or you, the participating study subject, have signed this form and, if of age, the child has given at minimum his/her verbal agreement.
What are the risks?
Subjects will undergo one blood draw. Blood sampling may cause minor stress, some pain and/or bruising at the site where the blood is taken.
What is the compensation?
Participants will receive $75 at the end of the first visit and $75 at the end of the second visit.
Who should I contact for more information?
Type 2 Diabetes Study Coordinators' Line
Cincinnati Children's Hospital Medical Center
Division of Preventive Cardiology
3333 Burnet Avenue, MLC 7002
Cincinnati, OH 45229-3039
Phone 513-636-1421
Email TYPE2CVDStudy@cchmc.org
CCHMC IRB Approval 04-12-50
