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

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

This study is currently recruiting participants.
Information provided by Massachusetts General Hospital

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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.

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study

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 ]

Secondary Outcome Measure ^†

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 ]

Condition ^†

Type 1 Diabetes Mellitus

Intervention ^†

Biological: BCG
Biological: Saline

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

November 2007

Completion Date

Eligibility Criteria ^†

Inclusion Criteria (Type 1 diabetic subjects):

Type 1 diabetes treated continuously with insulin from time of diagnosis
Age 18-45
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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Richard Pompei, RN BSN

617-726-2141

rpompei@partners.org

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00607230

Organization ID

2007-p-001347

Secondary IDs ^††

Study Sponsor ^†

Massachusetts General Hospital

Collaborators ^††

Iacocca Foundation

Investigators ^†

Principal Investigator:

David M Nathan, MD

Massachusetts General Hospital, Harvard Medical School

Information Provided By

Massachusetts General Hospital

Verification Date

July 2008

First Received Date ^†

January 22, 2008

Last Updated Date

July 7, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.