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, May 2010

First Received: January 22, 2008 Last Updated: May 3, 2010 History of Changes

Sponsor:	Massachusetts General Hospital
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control 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:

MedlinePlus related topics: Diabetes 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 ]

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
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 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

Contacts

Contact: Richard Pompei, RN BSN	617-726-2141	rpompei@partners.org
Contact: Richard Pompei, RN BSN	617-726-1847	rpompei@partners.org

Locations

United States, Massachusetts
Diabetes Research Center at Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Richard Pompei, RN, BSN 617-726-2141 rpompei@partners.org
Contact: Richard Pompei, RN, BSN 617-726-1847 rpompei@partners.org
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

No publications provided

Responsible Party:	Massachusetts General Hospital ( David M. Nathan, MD )
ClinicalTrials.gov Identifier:	NCT00607230 History of Changes
Other Study ID Numbers:	2007p-001347
Study First Received:	January 22, 2008
Last Updated:	May 3, 2010
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 September 01, 2010