drugset / Trial / NCT00568854

Immunobiology of Diabetes and Tuberculosis

NCT00568854

Terminated 10 enrolled Stanford University
Non-randomizedSingle-groupOpen-labelBasic science

Summary

The study hypothesis is that type 2 diabetics have abnormal cell-mediated immunity to tuberculosis manifesting as altered cytokine responses by peripheral blood mononuclear cells (PBMCs). This hypothesis will be tested using the live tuberculosis vaccine, Bacille Calmette-Guerin (BCG), in U.S.-born type 2 diabetics and nondiabetics. The investigators will control for potential confounding by age, sex, race, comorbidities, and select medications. Expression of key cytokines will be measured with real-time polymerase chain reaction.

Timeline

Start
2007-04
Primary completion
2008-03
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mycobax Vaccine 0.1 mg Other