Immunobiology of Diabetes and Tuberculosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Stanford University.
Recruitment status was  Active, not recruiting
Information provided by:
Stanford University Identifier:
First received: December 4, 2007
Last updated: June 12, 2008
Last verified: June 2008

Despite reports that diabetes mellitus increases the risk of tuberculosis by as much as 11-fold, few studies have focused on the underlying mechanism for this susceptibility. Our ultimate goal is to see if the higher TB rates in diabetics is due to depressed cellular immunity.

Condition Intervention
Diabetes Mellitus
Biological: BCG

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Secondary Outcome Measures:
  • Patterns of antigen-specific immune response

Estimated Enrollment: 34
Study Start Date: April 2007

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

No publications provided Identifier: NCT00568854     History of Changes
Other Study ID Numbers: SU-10182007-744
Study First Received: December 4, 2007
Last Updated: June 12, 2008
Health Authority: USA:Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections processed this record on September 18, 2014