Effects of GAD on the Progression of Type 1 Diabetes in New Onset Subjects (The GAD65 Research Study)
Principal Investigator: Peter Gottlieb, COMIRB #: 08-1338 Version: 12/01/08
The GAD65 Research Study is looking for people newly diagnosed with type 1 diabetes. The goal of this study is to learn if a vaccine, GAD-alum, could help people with newly diagnosed type 1 diabetes by delaying or stopping the further destruction of beta cells.
Why should you consider this study?
- You will be part of a research study to see if we can stop or slow down your body’s attack on the cells that produce insulin.
- If the proposed treatment is successful, you may have an easier time managing your diabetes.
- The information from this study may help other people with diabetes.
Who can sign up for this study?
- People who have been diagnosed with Type 1 Diabetes within the past 3 months.
- Age 3-45 years old. *
- Presence of GAD65 antibody.
*Age staggered enrollment
What will happen in this study?
- You will be assessed for general health and diabetes care.
- If you qualify, you will be assigned to one of three study groups: 3 injections of GAD-Alum, or 2 injections GAD-Alum and 1 injection placebo, or 3 injections placebo.
- You will be monitored for 2-4 years for assessment of beta cell function and diabetes care outcomes.
Who should I call with questions or to schedule an appointment?
Lisa Meyers: 303-724-6893 or Lisa.Meyers@ucdenver.edu
Susan George: 303-724-7501 or Susan.George@ucdenver.edu
http://www.clinicaltrials.gov |
