- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00568854
Immunobiology of Diabetes and Tuberculosis
Converging Epidemics: Immunobiology of Diabetes Mellitus and Tuberculosis Infection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Participants with diabetes
Persons with diagnosis of diabetes.
Received biological intervention: BCG
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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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ACTIVE_COMPARATOR: Participants without diabetes
Persons with no diagnosis of diabetes and negative diabetes screening labs.
Received biological intervention: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antigen-specific Immune Response Measured by Reaction to Tuberculin Skin Test
Time Frame: 5 months
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Participants had baseline tuberculin testing (TST), followed by BCG vaccination, and at 5 months after vaccination, study participants had repeat tuberculin skin testing done.
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5 months
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Kinetics of Mycobacterial-specific Immune Response After BCG Vaccination
Time Frame: 5 months
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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.
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5 months
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Collaborators and Investigators
Sponsor
Investigators
- Sub-Investigator: Alicia Hsin-Ming Chang, Stanford University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-10182007-744
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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