Back to resultsDetermination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BCG
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring type 1 diabetes mellitus, immune modulation, cure, autoimmunity
Eligibility 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
Sites / Locations
- Diabetes Research Center at Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
E
P
Arm Description
BCG vaccination
Saline vaccination
Outcomes
Primary Outcome Measures
concentration of autoreactive t-cells
Secondary Outcome Measures
Concentration of TNF, TNF-receptors, other cytokines, and c-peptide levels
Full Information
NCT ID
NCT00607230
First Posted
January 22, 2008
Last Updated
November 4, 2013
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00607230
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
type 1 diabetes mellitus, immune modulation, cure, autoimmunity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E
Arm Type
Experimental
Arm Description
BCG vaccination
Arm Title
P
Arm Type
Placebo Comparator
Arm Description
Saline vaccination
Intervention Type
Biological
Intervention Name(s)
BCG
Intervention Description
BCG vaccination at 0 and 4 weeks
Intervention Type
Biological
Intervention Name(s)
Saline
Intervention Description
Saline vaccination at 0 and 4 weeks
Primary Outcome Measure Information:
Title
concentration of autoreactive t-cells
Time Frame
Measured weekly in first 8 weeks, then every other week for weeks 8-12
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Nathan, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes Research Center at Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22905105
Citation
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.
Results Reference
derived
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Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics
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