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
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00568854
First received: December 4, 2007
Last updated: June 12, 2008
Last verified: June 2008
  Purpose

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
Tuberculosis
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
  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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
Tuberculosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 18, 2014