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

Mass General Brigham

Status and phase

Completed

Phase 1

Conditions

Type 1 Diabetes Mellitus

Treatments

Biological: BCG

Biological: Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT00607230

2007p-001347

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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