http://www.clinicaltrial.gov/ct2/show/NCT00607230?
term=bcg+diabetes&rank=1

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

This study is currently recruiting participants.
Verified by Massachusetts General Hospital, January 2008

Sponsors and Collaborators: Massachusetts General Hospital
Iacocca Foundation

Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00607230

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 I



MedlinePlus related topics: Diabetes Type 1

ChemIDplus related topics: Sodium chloride

U.S. FDA Resources

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

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


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 Primary Completion Date: July 2008 (Final data collection
date for primary outcome measure)


Arms Assigned Interventions
E: Experimental
BCG vaccination Biological: BCG
BCG vaccination at 0 and 4 weeks
P: Placebo Comparator
Saline vaccination Biological: Saline
Saline vaccination at 0 and 4 weeks



Eligibility
Ages Eligible for Study: 18 Years to 45 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 18-45
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
Contacts and Locations


Please refer to this study by its ClinicalTrials.gov identifier:
NCT00607230

Contacts


Contact: David M Nathan, MD DNATHAN@...
dnathan@...

Contact: Richard Pompei, RN BSN 617-726-2141


Locations


United States, Massachusetts
Diabetes Research Center at Massachusetts General Hospital
Enrolling by invitation
Boston, Massachusetts, United States, 02114
MGH Diabetes Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Richard Pompei, RN 617-726-1847
RPompei@...
Principal Investigator: David M Nathan, MD


Sponsors and Collaborators


Massachusetts General Hospital

Iacocca Foundation


Investigators


Principal Investigator: David M Nathan, MD Massachusetts
General Hospital, Harvard Medical School

More Information

Responsible Party: Massachusetts General Hospital ( David M.
Nathan, MD )
Study ID Numbers: 2007-p-001347
First Received: January 22, 2008
Last Updated: February 4, 2008
ClinicalTrials.gov Identifier: NCT00607230
Health Authority: United States: Food and Drug Administration


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




Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Immune System Diseases
Endocrine System Diseases
Nutritional and Metabolic Diseases
Diabetes Mellitus

ClinicalTrials.gov processed this record on March 13, 2008