| January 22, 2008 |
| November 4, 2009 |
| November 2007 |
| December 2009 (final data collection date for primary outcome measure) |
| concentration of autoreactive t-cells [ Time Frame: Measured weekly in first 8 weeks, then every other week for weeks 8-12 ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00607230 on ClinicalTrials.gov Archive Site |
| 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 ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics |
| Determination of Dosing and Frequency of BCG Administration Necessary to Alter T-Lymphocyte Profiles in Type I Diabetics |
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. 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. |
| |
| Phase I |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
| Type 1 Diabetes Mellitus |
- Biological: BCG
- Biological: Saline
|
- Experimental: BCG vaccination
- Placebo Comparator: Saline vaccination
|
| |
| |
| Recruiting |
| 25 |
| February 2010 |
| December 2009 (final data collection date for primary outcome measure) |
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):
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
|
| Both |
| 18 Years to 55 Years |
| Yes |
|
|
| United States |
| |
| NCT00607230 |
| David M. Nathan, MD, Massachusetts General Hospital |
| 2007p-001347 |
| Massachusetts General Hospital |
| Iacocca Foundation |
| Principal Investigator: |
David M Nathan, MD |
Massachusetts General Hospital, Harvard Medical School |
|
|
| Massachusetts General Hospital |
| November 2009 |
