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Trial record 2 of 5 for:    bcg diabetes

Immunobiology of Diabetes and Tuberculosis

This study has been terminated.
(Additional funding was not secured)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00568854
First Posted: December 6, 2007
Last Update Posted: August 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alicia H. Chang, MD, Stanford University
  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. 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.

Condition Intervention
Tuberculosis Diabetes Mellitus Biological: BCG

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Converging Epidemics: Immunobiology of Diabetes Mellitus and Tuberculosis Infection

Resource links provided by NLM:


Further study details as provided by Alicia H. Chang, MD, Stanford University:

Primary Outcome Measures:
  • Antigen-specific Immune Response Measured by Reaction to Tuberculin Skin Test [ Time Frame: 5 months ]
    Participants had baseline tuberculin testing (TST), followed by BCG vaccination, and at 5 months after vaccination, study participants had repeat tuberculin skin testing done.

  • Kinetics of Mycobacterial-specific Immune Response After BCG Vaccination [ Time Frame: 5 months ]
    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.


Enrollment: 10
Study Start Date: April 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Participants with diabetes
Persons with diagnosis of diabetes. 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.
Active Comparator: Participants without diabetes
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568854


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Sub-Investigator: Alicia Hsin-Ming Chang Stanford University
Principal Investigator: Julie Parsonnet Stanford University
  More Information

Responsible Party: Alicia H. Chang, MD, Instructor, Stanford University
ClinicalTrials.gov Identifier: NCT00568854     History of Changes
Other Study ID Numbers: SU-10182007-744
First Submitted: December 4, 2007
First Posted: December 6, 2007
Results First Submitted: April 12, 2016
Results First Posted: August 16, 2016
Last Update Posted: August 16, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Tuberculosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections