This study will enroll 20 adult, honeymooning type-1 diabetics. Half will get the drug, half a placebo. Treatment will be TUDCA pills each day for a year. C-peptide levels after a meal are the primary outcome, and will be measured for 18 months. They will also check liver function, as a safety issue. They hope to complete the study by December 2018. This clinical trial is funded by JDRF. (Note that the study is officially phase-II, but I consider it phase-I because of it's size and first-in-type-1 nature.)
This study is recruiting at one site:
Naomi Berrie Diabetes Center, Columbia University, 1150 St. Nicholas Ave.
New York, New York, United States, 10032
Contact: Ellen Greenberg, MA 212-851-5425 firstname.lastname@example.org
Contact: Robin Goland, MD 212-851-5492 email@example.com
Why Test TUDCA? TUDCA has been found to relieve stress in a particular part of the beta cell (called the ER). The hope is, by lowering this stress, beta cells will not be killed, and either type-1 will not occur, or it will be less severe, or be delayed. This is based on type-1 diabetes being caused by the following chain of events:
Autoimmune attack –causes→ ER stress –causes→ Type-1 Diabetesso if you can stop/lessen/delay the ER stress you can stop/lessen/delay type-1 diabetes.
3 Minute Video: https://vimeo.com/118597801
Information For Patients: http://www.nbdiabetes.org/news/unique-jdrf-funded-clinical-trial-tudca
Press Release and Video: http://jdrf.org/blog/2015/02/09/t1d-trial-looks-to-teach-an-old-drug-new-tricks/
Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT02218619
Wikipedia entry: https://en.wikipedia.org/wiki/Tauroursodeoxycholic_acid
Earlier News Article: http://www.hsph.harvard.edu/news/press-releases/newly-discovered-mechanism-suggests-novel-approach-to-prevent-type-1-diabetes/
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.