Trial record 2 of 5 for:    bcg diabetes

Immunobiology of Diabetes and Tuberculosis

This study has been terminated.
(Additional funding was not secured)
Information provided by (Responsible Party):
Alicia H. Chang, MD, Stanford University Identifier:
First received: December 4, 2007
Last updated: February 12, 2015
Last verified: February 2015
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
Diabetes Mellitus
Biological: BCG

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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 Stanford University:

Primary Outcome Measures:
  • Antigen-specific immune response [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patterns of antigen-specific immune response [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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.


Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00568854

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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 Identifier: NCT00568854     History of Changes
Other Study ID Numbers: SU-10182007-744 
Study First Received: December 4, 2007
Last Updated: February 12, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Actinomycetales Infections
Bacterial Infections
Endocrine System Diseases
Glucose Metabolism Disorders
Gram-Positive Bacterial Infections
Metabolic Diseases
Mycobacterium Infections processed this record on May 24, 2016