NCT00568854

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
8.5 years until next milestone

Results Posted

Study results publicly available

August 16, 2016

Completed
Last Updated

August 16, 2016

Status Verified

June 1, 2016

Enrollment Period

11 months

First QC Date

December 4, 2007

Results QC Date

April 12, 2016

Last Update Submit

June 30, 2016

Conditions

TuberculosisDiabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Antigen-specific Immune Response Measured by Reaction to Tuberculin Skin Test

    Participants had baseline tuberculin testing (TST), followed by BCG vaccination, and at 5 months after vaccination, study participants had repeat tuberculin skin testing done.

    5 months

  • Kinetics of Mycobacterial-specific Immune Response After BCG Vaccination

    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.

    5 months

Study Arms (2)

Participants with diabetes

ACTIVE COMPARATOR

Persons with diagnosis of diabetes. Received biological intervention: BCG

Biological: BCG

Participants without diabetes

ACTIVE COMPARATOR

Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.

Biological: BCG

Interventions

BCGBIOLOGICAL

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.

Participants with diabetesParticipants without diabetes

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Immunosuppressive medications
  • Pregnancy
  • Renal failure
  • Advanced pulmonary disease
  • Prior BCG vaccination
  • Prior TB infection
  • Type 1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

TuberculosisDiabetes Mellitus

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

This was a pilot/feasibility study to lay groundwork for a larger scale study of differences in immune responses in persons with diabetes versus persons without diabetes. The study aimed to optimize laboratory procedures for the full study.

Results Point of Contact

Title
Dr. Alicia Chang
Organization
Los Angeles County Department of Public Health
alchang@ph.lacounty.gov
213-745-0846

Study Officials

  • Alicia Hsin-Ming Chang

    Stanford University

    SUB INVESTIGATOR

  • Julie Parsonnet

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 6, 2007

Study Start

April 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

August 16, 2016

Results First Posted

August 16, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)