- www.montefiore.org/body.cfm?id=2342&Verified April 2015 by Joslin Diabetes CenterSponsor:Alessandro DoriaCollaborators:Juvenile Diabetes Research FoundationJoslin Diabetes CenterUniversity of Minnesota - Clinical and Translational Science InstituteUniversity of Colorado, DenverUniversity of MichiganUniversity of TorontoFeinberg School of Medicine, Northwestern UniversityAlbert Einstein College of Medicine of Yeshiva UniversitySteno Diabetes CenterWashington University School of MedicineUniversity of WashingtonEmory UniversityUniversity of CalgaryUniversity of AlbertaInformation provided by (Responsible Party):Alessandro Doria, Joslin Diabetes Center
Bronx Yankees to quit scamming Type 1 diabetics and give them a choice of safe effective treatment, BCG.
BCG beats allopurinol as easily as the Boston Red Sox stomp the Yankees.
Shoot BCG at less than a vaccination dose again and again and you will prevent kidney function loss in Type 1 diabetics and MUCH MORE!!!
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A Multicenter Clinical Trial of
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A Multicenter Clinical Trial of Allopurinol to Prevent Kidney Function Loss in Type 1 Diabetes: ... (718) 405-8271: Contact Email : PERL@einstein.yu.edu: Protocol ...
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Watch Dr. Faustman's interview about the Phase I trialYour donation will directly support our Phase II research.
Raised to date: $18.4 million
Our total need: $25.2 million.------------Interested in the Phase II Trial?The Faustman Lab at Massachusetts General HospitalDenise Faustman, MD, PhD, is Director of the Immunobiology Laboratory at the Massachusetts General Hospital (MGH) and an Associate Professor of Medicine at Harvard Medical School. Her current research focuses on discovering and developing new treatments for type 1 diabetes and other autoimmune diseases, including Crohn's disease, lupus, scleroderma, rheumatoid arthritis, Sjögren's syndrome, and multiple sclerosis. She is currently leading a human clinical trial program testing the efficacy of the BCG vaccine for reversal of long-term type 1 diabetes. Positive results from the Phase I study were reported in 2012.
Dr. Faustman's type 1 diabetes research has earned her notable awards such as the Oprah Achievement Award for “Top Health Breakthrough by a Female Scientist” (2005), the "Women in Science Award" from the American Medical Women’s Association and Wyeth Pharmaceutical Company for her contributions to autoimmune disease research (2006), and the Goldman Philanthropic Partnerships/Partnership for Cures “George and Judith Goldman Angel Award” for research to find an effective treatment for type 1 diabetes (2011). Her previous research accomplishments include the first scientific description of modifying donor tissue antigens to change their foreignness. This achievement earned her the prestigious National Institutes of Health and National Library of Medicine “Changing the Face of Medicine” Award (2003) as one of 300 American physicians (one of 35 in research) honored for seminal scientific achievements in the United States.
Dr. Faustman earned her MD and PhD from Washington University School of Medicine in St. Louis, Missouri, and completed her internship, residency, and fellowships in Internal Medicine and Endocrinology at the Massachusetts General Hospital in Boston, Massachusetts.
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Title A Multicenter Clinical Trial of Allopurinol to Prevent Kidney Function Loss in Type 1 Diabetes Disease/Condition Diabetes and Endocrine Description Click here for more information Eligibility Criteria Ages Eligible for Study: 18 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Click here for eligibility requirementsPrincipal Investigator Jill Crandall, MD Contact Name Danielle Powell Phone (718) 405-8271 Contact Email PERL@einstein.yu.edu Protocol Number IRB# 2013-374 Inclusion/Notes This information was obtained from ClinicalTrials.gov.
Status Enrolling Adult Clinical Trial Yes Pediatric Clinical Trial No 
© 2015 Montefiore Medical Center | 111 East 210th Street, Bronx, NY 10467 | 718-920-4321
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Purpose
Despite improvements during the past 20 years in blood glucose and blood pressure control, diabetic kidney disease remains one of the most important causes of health problems in patients with diabetes. Novel treatments to complement blood glucose and blood pressure control are urgently needed. The goal of this study is to see whether a medication called allopurinol may help prevent loss of kidney function among people with type 1 diabetes. Allopurinol has been used for many years to decrease high blood uric acid and treat gout - a disease characterized by arthritis, especially of the foot joints. There is evidence suggesting that allopurinol might also be useful in people with diabetes who have normal or moderately impaired kidney function to decrease the risk of developing advanced kidney disease in the future. To prove this beneficial effect of allopurinol, we will be conducting an international clinical trial at eight diabetes centers, enrolling approximately 480 patients with type 1 diabetes who are at increased risk of developing kidney disease. Participants will be randomly assigned to take allopurinol or placebo (inactive pill) for three years, during which they will be followed through periodical visits. To prevent any possible bias, neither the participants nor the clinical staff knows who is taking allopurinol and who is taking the placebo. Kidney function will be measured at the beginning and at the end of the treatment period to see whether patients taking allopurinol experience a slower loss of kidney function over time as compared to those taking the inactive pill. If this trial is successful, the reduction in health problems resulting from the prevention or delay of kidney function loss due to the use of allopurinol would have a major impact on the lives of type 1 diabetic patients as well as on society at large, significantly reducing the human and financial costs associated with diabetic kidney disease. Because of the emphasis on early intervention, the proposed trial, if successful, will establish a new paradigm in treatments to slow or prevent progression towards end stage kidney disease in type 1 diabetes far beyond anything achieved to date.
Result Filters
PLoS One. 2012;7(8):e41756. doi: 10.1371/journal.pone.0041756. Epub 2012 Aug 8.Proof-of-concept, randomized, controlled clinical trial of Bacillus-Calmette-Guerin for treatment of long-term type 1 diabetes.
Faustman DL1, Wang L, Okubo Y, Burger D, Ban L, Man G, Zheng H, Schoenfeld D, Pompei R, Avruch J, Nathan DM.Abstract
BACKGROUND:
No targeted immunotherapies reverse type 1 diabetes in humans. However, in a rodent model of type 1 diabetes, Bacillus Calmette-Guerin (BCG) reverses disease by restoring insulin secretion. Specifically, it stimulates innate immunity by inducing the host to produce tumor necrosis factor (TNF), which, in turn, kills disease-causing autoimmune cells and restores pancreatic beta-cell function through regeneration.
METHODOLOGY/PRINCIPAL FINDINGS:
Translating these findings to humans, we administered BCG, a generic vaccine, in a proof-of-principle, double-blind, placebo-controlled trial of adults with long-term type 1 diabetes (mean: 15.3 years) at one clinical center in North America. Six subjects were randomly assigned to BCG or placebo and compared to self, healthy paired controls (n = 6) or reference subjects with (n = 57) or without (n = 16) type 1 diabetes, depending upon the outcome measure. We monitored weekly blood samples for 20 weeks for insulin-autoreactive T cells, regulatory T cells (Tregs), glutamic acid decarboxylase (GAD) and other autoantibodies, and C-peptide, a marker of insulin secretion. BCG-treated patients and one placebo-treated patient who, after enrollment, unexpectedly developed acute Epstein-Barr virus infection, a known TNF inducer, exclusively showed increases in dead insulin-autoreactive T cells and induction of Tregs. C-peptide levels (pmol/L) significantly rose transiently in two BCG-treated subjects (means: 3.49 pmol/L [95% CI 2.95-3.8], 2.57 [95% CI 1.65-3.49]) and the EBV-infected subject (3.16 [95% CI 2.54-3.69]) vs.1.65 [95% CI 1.55-3.2] in reference diabetic subjects. BCG-treated subjects each had more than 50% of their C-peptide values above the 95(th) percentile of the reference subjects. The EBV-infected subject had 18% of C-peptide values above this level.
CONCLUSIONS/SIGNIFICANCE:
We conclude that BCG treatment or EBV infection transiently modified the autoimmunity that underlies type 1 diabetes by stimulating the host innate immune response. This suggests that BCG or other stimulators of host innate immunity may have value in the treatment of long-term diabetes.
TRIAL REGISTRATION:
ClinicalTrials.gov NCT00607230.Comment in
- Targeting innate immunity to treat long-term type 1 diabetes. [Regen Med. 2012]
- PMID:
- 22905105
- [PubMed - indexed for MEDLINE]
- PMCID:
- PMC3414482
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- Verified April 2015 by Joslin Diabetes CenterSponsor:Alessandro DoriaCollaborators:Juvenile Diabetes Research FoundationJoslin Diabetes CenterUniversity of Minnesota - Clinical and Translational Science InstituteUniversity of Colorado, DenverUniversity of MichiganUniversity of TorontoFeinberg School of Medicine, Northwestern UniversityAlbert Einstein College of Medicine of Yeshiva UniversitySteno Diabetes CenterWashington University School of MedicineUniversity of WashingtonEmory UniversityUniversity of CalgaryUniversity of AlbertaInformation provided by (Responsible Party):Alessandro Doria, Joslin Diabetes CenterClinicalTrials.gov Identifier:NCT02017171First received: December 16, 2013Last updated: April 9, 2015Last verified: April 2015
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Purpose
Despite improvements during the past 20 years in blood glucose and blood pressure control, diabetic kidney disease remains one of the most important causes of health problems in patients with diabetes. Novel treatments to complement blood glucose and blood pressure control are urgently needed. The goal of this study is to see whether a medication called allopurinol may help prevent loss of kidney function among people with type 1 diabetes. Allopurinol has been used for many years to decrease high blood uric acid and treat gout - a disease characterized by arthritis, especially of the foot joints. There is evidence suggesting that allopurinol might also be useful in people with diabetes who have normal or moderately impaired kidney function to decrease the risk of developing advanced kidney disease in the future. To prove this beneficial effect of allopurinol, we will be conducting an international clinical trial at eight diabetes centers, enrolling approximately 480 patients with type 1 diabetes who are at increased risk of developing kidney disease. Participants will be randomly assigned to take allopurinol or placebo (inactive pill) for three years, during which they will be followed through periodical visits. To prevent any possible bias, neither the participants nor the clinical staff knows who is taking allopurinol and who is taking the placebo. Kidney function will be measured at the beginning and at the end of the treatment period to see whether patients taking allopurinol experience a slower loss of kidney function over time as compared to those taking the inactive pill. If this trial is successful, the reduction in health problems resulting from the prevention or delay of kidney function loss due to the use of allopurinol would have a major impact on the lives of type 1 diabetic patients as well as on society at large, significantly reducing the human and financial costs associated with diabetic kidney disease. Because of the emphasis on early intervention, the proposed trial, if successful, will establish a new paradigm in treatments to slow or prevent progression towards end stage kidney disease in type 1 diabetes far beyond anything achieved to date.
Condition Intervention Phase Diabetic Nephropathies
Coronary Artery Disease
Drug: Allopurinol
Drug: Placebo
Phase 3
Study Type: Interventional Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: PreventionOfficial Title: PERL: A Multicenter Clinical Trial of Allopurinol to Prevent GFR Loss in T1D
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