Immunobiology of Diabetes and Tuberculosis

Stanford University

Status: Terminated

Conditions: Tuberculosis; Diabetes Mellitus

Treatments: Biological: BCG

Study type: Interventional

Funder types: Other

Identifiers

NCT00568854

SU-10182007-744

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Participants with diabetes

Active Comparator group

Description:

Persons with diagnosis of diabetes. Received biological intervention: BCG

Treatment:

Biological: BCG

Participants without diabetes

Active Comparator group

Description:

Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.

Treatment:

Biological: BCG