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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Iacocca Foundation
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00607230
First received: January 22, 2008
Last updated: January 5, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
 Biological: BCG
Biological: Saline
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: November 2007
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E
BCG vaccination
 Biological: BCG
BCG vaccination at 0 and 4 weeks
Placebo Comparator: P
Saline vaccination
 Biological: Saline
Saline vaccination at 0 and 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607230

Locations
United States, Massachusetts
Diabetes Research Center at Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Iacocca Foundation
Investigators
Principal Investigator: David M Nathan, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: David M. Nathan, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00607230     History of Changes
Other Study ID Numbers: 2007p-001347
Study First Received: January 22, 2008
Last Updated: January 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
type 1 diabetes mellitus
immune modulation
cure
autoimmunity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013