Diabetes Mellitus Clinical Trial
Official title:
Converging Epidemics: Immunobiology of Diabetes Mellitus and Tuberculosis Infection
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.
The project has three specific aims:
Specific Aim 1: To assess differences between the study groups in cytokine expression before
and after BCG vaccination. The investigators will determine within-individual variability in
cytokine measurements and describe the kinetics of cytokine response to BCG. Peak response
levels, time to peak, and patterns of cytokines expressed will be compared.
Specific Aim 2: To evaluate the effect of hyperglycemia on the cytokine response of type 2
diabetics. The investigators will evaluate whether levels of hemoglobin A1C (HbA1C) are
associated with degree of cytokine response and test if type 2 diabetics who have good
glucose control are different from nondiabetics.
Specific Aim 3: To evaluate the effect of testing PBMCs from diabetics outside of their
diabetic milieu. Investigators will compare the BCG-specific cytokine responses of PBMCs
stimulated in normal medium, PBMCs stimulated in glucose correlating to the person's most
recent HbA1C, and whole blood samples.
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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