An interventional study of BCG in Tuberculosis and Diabetes Mellitus, sponsored by Stanford University. Terminated at 1 site in United States. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-16.
Sponsored by Stanford University · Not applicable, Interventional, and Basic science
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.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 10 is below the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:Type 2 diabetes or healthy individual Able to give consent US-born Age 30-65 Exclusion Criteria:* Immunosuppressive disease
Persons with diagnosis of diabetes. Received biological intervention: BCG
Biological: BCG
Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.
Biological: BCG
Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication.
Antigen-specific Immune Response Measured by Reaction to Tuberculin Skin Test
Participants had baseline tuberculin testing (TST), followed by BCG vaccination, and at 5 months after vaccination, study participants had repeat tuberculin skin testing done.
Time frame: 5 months
Kinetics of Mycobacterial-specific Immune Response After BCG Vaccination
Blood was sampled at times 0, 2, 4, 6, 8, 12, 16, and 20 weeks post BCG vaccination and Interferon gamma production was measured as change from pre-vaccination baseline. Timeline of peak IFn-g response was measured for both study groups.
Time frame: 5 months
| Milestone | Participants With Diabetes | Participants Without Diabetes |
|---|---|---|
| Started | 6 | 4 |
| Completed | 6 | 4 |
| Not completed | 0 | 0 |
Participants had baseline tuberculin testing (TST), followed by BCG vaccination, and at 5 months after vaccination, study participants had repeat tuberculin skin testing done.
| mm | Participants With Diabetes | Participants Without Diabetes |
|---|---|---|
| Antigen-specific Immune Response Measured by Reaction to Tuberculin Skin Test | 0 (0 to 10) | 3 (0 to 6) |
Blood was sampled at times 0, 2, 4, 6, 8, 12, 16, and 20 weeks post BCG vaccination and Interferon gamma production was measured as change from pre-vaccination baseline. Timeline of peak IFn-g response was measured for both study groups.
| weeks when peak response was observed | Participants With Diabetes | Participants Without Diabetes |
|---|---|---|
| Kinetics of Mycobacterial-specific Immune Response After BCG Vaccination | 8 ± 1 | 8 ± 1 |
Collected over 5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With Diabetes | — | 0/6 (0%) | 0/6 (0%) |
| Participants Without Diabetes | — | 0/4 (0%) | 0/4 (0%) |
| Age, Continuous(years) | Participants With Diabetes | Participants Without Diabetes | Total |
|---|---|---|---|
| Median | 59.5 (54 to 65) | 41.5 (32 to 46) | 54.5 (32 to 65) |
| Sex: Female, Male(Participants) | Participants With Diabetes | Participants Without Diabetes | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 3 | 1 | 4 |
| Race (NIH/OMB)(Participants) | Participants With Diabetes | Participants Without Diabetes | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 5 | 3 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Hemoglobin A1C(%) | Participants With Diabetes | Participants Without Diabetes | Total |
|---|---|---|---|
| Median | 6.65 (6.1 to 7.5) | 5.65 (5.6 to 5.7) | 6.1 (5.6 to 7.5) |
Plan to share: No
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