Expired Study
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Stanford, California 94305


Purpose:

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. We 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.


Study summary:

The project has three specific aims: Specific Aim 1: To assess differences between the study groups in cytokine expression before and after BCG vaccination. We will determine within-individual variability in cytokine measurements and describe the kinetics of cytokine response to BCG. We will compare peak response levels, time to peak, and patterns of cytokines expressed. Specific Aim 2: To evaluate the effect of hyperglycemia on the cytokine response of type 2 diabetics. We 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. We 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.


Criteria:

Inclusion Criteria:Type 2 diabetes or healthy individual Able to give consent US-born Age 30-65 Exclusion Criteria:* Immunosuppressive disease - Immunosuppressive medications - Pregnancy - Renal failure - Advanced pulmonary disease - Prior BCG vaccination - Prior TB infection - Type 1 diabetes


NCT ID:

NCT00568854


Primary Contact:

Sub-Investigator
Alicia Hsin-Ming Chang
Stanford University


Backup Contact:

N/A


Location Contact:

Stanford, California 94305
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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