Type 1 Diabetes Prevention with TUDCA, Phase-1 Trial
A phase-1 trial for type 1 diabetes prevention with the FDA-approved drug, TUDCA has begun. TUDCA affects a molecular pathway that contributes to the malfunction of insulin-producing pancreatic beta cells in type 1 diabetes in human patients and in mice, and may help beta cells function properly and survive. Currently, there is no cure or preventive regimen for type 1 diabetes.
Tauroursodeoxycholic Acid (also known as TUDCA or Taurolite) is a chemical found in bile (especially bear bile). Mouse and rat studies have found that TUDCA can preserve beta cells, and it is already approved for us in Europe for relatively rare liver diseases. It is also widely available as a “dietary supplement” in the US.
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. (Note that the study is officially phase-II, but should be considered it phase-I because of its 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 diabetes 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 Diabetes
If you can stop/lessen/delay the ER stress you can stop/lessen/delay type-1 diabetes.
Health-e-Solutions comment: This study breaks new ground because it focuses on boosting beta cell performance and shows that beta cell preservation is possible even in the face of the autoimmune attack involved in type 1 diabetes progression. #CuringType1Diabetes is the ultimate goal, but preventing it from progressing is also a worthy goal for those who have not yet lost all beta cell function – a significant portion of the type 1 diabetes community.
Until CuringType1Diabetes is a reality, put your body in a position of strength to #MasterDiabetes the healthiest way possible. Lifestyle innovations as a priority over drug therapies may be the solution. Poor health feeds poor health in a vicious cycle, or negative feedback loop that is increasingly difficult to break the longer it continues. Promoting, supporting and creating health set in motion a positive feedback loop instead. Get tools and solutions to help minimize consequences and maximize benefits for nutrition, environment, exercise, sleep and stress management. These five health components make up the five pillars of health and nutrition in the Health-e-Solutions lifestyle. We’ll teach you how to improve each of these areas to help you #MasterDiabetesNaturally – the healthiest way possible.
- Information For Patients: http://www.nbdiabetes.org/news/unique-jdrf-funded-clinical-trial-tudca
- 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/