Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics
NCT ID: NCT00607230
Last Updated: 2013-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2007-11-30
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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E
BCG vaccination
BCG
BCG vaccination at 0 and 4 weeks
P
Saline vaccination
Saline
Saline vaccination at 0 and 4 weeks
Interventions
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BCG
BCG vaccination at 0 and 4 weeks
Saline
Saline vaccination at 0 and 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Age 18-55
* Anti-GAD positive
* HIV antibody negative
* Normal CBC
* Negative intermediate PPD test performed and read by study staff
* HCG Negative (females)
* Age 18-45
Exclusion Criteria
* 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).
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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David M. Nathan, MD
Director, Diabetes Center
Principal Investigators
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David M Nathan, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Diabetes Research Center at Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
Other Identifiers
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2007p-001347
Identifier Type: -
Identifier Source: org_study_id