Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics
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ClinicalTrials.gov Identifier: NCT00607230 |
Recruitment Status :
Completed
First Posted : February 5, 2008
Last Update Posted : November 5, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes Mellitus | Biological: BCG Biological: Saline | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Determination of Dosing and Frequency of BCG Administration Necessary to Alter T-Lymphocyte Profiles in Type I Diabetics |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | February 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: E
BCG vaccination
|
Biological: BCG
BCG vaccination at 0 and 4 weeks |
Placebo Comparator: P
Saline vaccination
|
Biological: Saline
Saline vaccination at 0 and 4 weeks |
- concentration of autoreactive t-cells [ Time Frame: Measured weekly in first 8 weeks, then every other week for weeks 8-12 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607230
United States, Massachusetts | |
Diabetes Research Center at Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | David M Nathan, MD | Massachusetts General Hospital |
Responsible Party: | David M. Nathan, MD, Director, Diabetes Center, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00607230 |
Other Study ID Numbers: |
2007p-001347 |
First Posted: | February 5, 2008 Key Record Dates |
Last Update Posted: | November 5, 2013 |
Last Verified: | November 2013 |
type 1 diabetes mellitus immune modulation cure autoimmunity |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |