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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with diabetes | Active Comparator | Persons with diagnosis of diabetes. Received biological intervention: BCG |
|
| Participants without diabetes | Active Comparator | Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCG | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 5 months |
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Inclusion Criteria:Type 2 diabetes or healthy individual Able to give consent US-born Age 30-65 Exclusion Criteria:* Immunosuppressive disease
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| Name | Affiliation | Role |
|---|---|---|
| Alicia Hsin-Ming Chang | Stanford University | Sub-Investigator |
| Julie Parsonnet | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Diabetes | Persons with diagnosis of diabetes. Received biological intervention: BCG 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. |
| FG001 | Participants Without Diabetes | Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Diabetes | Persons with diagnosis of diabetes. Received biological intervention: BCG 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | mm | 5 months |
|
5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Diabetes | Persons with diagnosis of diabetes. Received biological intervention: BCG 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. |
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This was a pilot/feasibility study to lay groundwork for a larger scale study of differences in immune responses in persons with diabetes versus persons without diabetes. The study aimed to optimize laboratory procedures for the full study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alicia Chang | Los Angeles County Department of Public Health | 213-745-0846 | alchang@ph.lacounty.gov |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Participants Without Diabetes |
Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Hemoglobin A1C | Median | Full Range | % |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | weeks when peak response was observed | 5 months |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Participants Without Diabetes | Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG. 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. | 0 | 4 | 0 | 4 |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |