Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics

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.
 
ClinicalTrials.gov Identifier: NCT00607230
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : November 5, 2013
Sponsor:
Information provided by (Responsible Party):
David M. Nathan, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE January 22, 2008
First Posted Date  ICMJE February 5, 2008
Last Update Posted Date November 5, 2013
Study Start Date  ICMJE November 2007
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2008)
concentration of autoreactive t-cells [ Time Frame: Measured weekly in first 8 weeks, then every other week for weeks 8-12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2008)
Concentration of TNF, TNF-receptors, other cytokines, and c-peptide levels [ Time Frame: Weekly for first 8 weeks, then every other week for weeks 8-12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics
Official Title  ICMJE Determination of Dosing and Frequency of BCG Administration Necessary to Alter T-Lymphocyte Profiles in Type I Diabetics
Brief Summary Type 1 diabetes is caused by an autoimmune destruction of the insulin producing cells of the pancreas. The investigators have discovered the specific autoimmune cells responsible for destroying the insulin-producing cells in an animal model of type 1 diabetes, and the means of destroying those cells.
Detailed Description The investigators are now aiming to use a similar strategy (vaccination with BCG, the vaccine used world-wide to protect against tuberculosis) in human type 1 diabetes to see if the abnormal immune cells can be depleted. This is the first step in trying to cure established type 1 diabetes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Biological: BCG
    BCG vaccination at 0 and 4 weeks
  • Biological: Saline
    Saline vaccination at 0 and 4 weeks
Study Arms  ICMJE
  • Experimental: E
    BCG vaccination
    Intervention: Biological: BCG
  • Placebo Comparator: P
    Saline vaccination
    Intervention: Biological: Saline
Publications * Faustman DL, Wang L, Okubo Y, Burger D, Ban L, Man G, Zheng H, Schoenfeld D, Pompei R, Avruch J, Nathan DM. Proof-of-concept, randomized, controlled clinical trial of Bacillus-Calmette-Guerin for treatment of long-term type 1 diabetes. PLoS One. 2012;7(8):e41756. doi: 10.1371/journal.pone.0041756. Epub 2012 Aug 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2008)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria (Type 1 diabetic subjects):

  • Type 1 diabetes treated continuously with insulin from time of diagnosis
  • Age 18-55
  • Anti-GAD positive
  • HIV antibody negative
  • Normal CBC
  • Negative intermediate PPD test performed and read by study staff
  • HCG Negative (females)

Exclusion Criteria Type 1 diabetic subjects):

  • History of chronic infectious disease, such as HIV
  • History of tuberculosis, TB risk factors, or history of + PPD, or BCG vaccination
  • Treatment with glucocorticoids (other than intermittent nasal steroids) or disease or condition likely to require steroid therapy
  • Other conditions or treatments associated with increased risk of infections such as patients with previous history of severe burns, or treatment with immunosuppressive medications of any type (e.g. imuran, methotrexate, cyclosporine, etanercept, infliximab) for any reason
  • Current treatment with aspirin > 160 mg/day or chronic, daily NSAIDs
  • Fasting or stimulated (1 mg glucagon stimulation test) c-peptide > 0.2 pmol/mL
  • History of keloid formation
  • HbA1c > 8.0%
  • History or evidence of chronic kidney disease (serum creatinine > 1.5 mg/dL)
  • History of proliferative diabetic retinopathy that has not been treated with laser therapy
  • Pregnant or not using acceptable birth control
  • Living with someone who is immunosuppressed and/or at high risk for infectious diseases (for example HIV+ or taking immunosuppressive medications for any reason).

Inclusion Criteria (Control Non-diabetic Subjects):

  • Age 18-45

Exclusion Criteria (Control Non-diabetic Subjects):

  • History of autoimmune diseases or diabetes
  • History of HIV History of autoimmune disease or type 1 diabetes (use of insulin continuously since diagnosis) in first degree family members
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00607230
Other Study ID Numbers  ICMJE 2007p-001347
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David M. Nathan, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David M Nathan, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP