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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E | Experimental | BCG vaccination |
|
| P | Placebo Comparator | Saline vaccination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCG | Biological | BCG vaccination at 0 and 4 weeks |
| |
| Saline |
| Measure | Description | Time Frame |
|---|---|---|
| concentration of autoreactive t-cells | Measured weekly in first 8 weeks, then every other week for weeks 8-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of TNF, TNF-receptors, other cytokines, and c-peptide levels | Weekly for first 8 weeks, then every other week for weeks 8-12 |
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Inclusion Criteria (Type 1 diabetic subjects):
Exclusion Criteria Type 1 diabetic subjects):
Inclusion Criteria (Control Non-diabetic Subjects):
Exclusion Criteria (Control Non-diabetic Subjects):
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| Name | Affiliation | Role |
|---|---|---|
| David M Nathan, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Research Center at Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22905105 | Derived | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Biological |
Saline vaccination at 0 and 4 weeks |
|
| D004700 | Endocrine System Diseases |
| D007154 | Immune System Diseases |
| D017670 |
| Sodium Compounds |