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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
Sandy Barry: 303-724-7501 or Sandra.Barry@ucdenver.edu

http://www.clinicaltrials.gov