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

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.

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:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

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 ]


Enrollment:	25
Study Start Date:	November 2007
Study Completion Date:	February 2011
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

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.

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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):

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.


Responsible Party:	David M. Nathan, MD, Director, Diabetes Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00607230 History of Changes
Other Study ID Numbers:	2007p-001347
Study First Received:	January 22, 2008
Last Updated:	November 4, 2013
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 Autoimmune Diseases Endocrine System Diseases	Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases

ClinicalTrials.gov processed this record on February 27, 2015