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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00607230
• Date of registration: 22/01/2008
• Primary sponsor: Massachusetts General Hospital
• Public title: Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics
• Scientific title: Determination of Dosing and Frequency of BCG Administration Necessary to Alter T-Lymphocyte Profiles in Type I Diabetics
• Date of first enrolment: November 2007
• Target sample size: 25
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00607230
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: David M Nathan, MD
• Affiliation: Massachusetts General Hospital

Key inclusion & 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 1 Diabetes Mellitus

Intervention(s)

Biological: BCG

Biological: Saline

Primary Outcome(s)

concentration of autoreactive t-cells [Time Frame: Measured weekly in first 8 weeks, then every other week for weeks 8-12]

Secondary Outcome(s)

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]

Secondary ID(s)

2007p-001347

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Iacocca Foundation