Tauroursodeoxycholic Acid (TUDCA) in New-Onset Type 1 Diabetes
Completed · Phase 2 · Has a placebo group
Conditions studied: Type 1 Diabetes
In brief
Clinically, the ability to slow or prevent beta cell demise can prevent or improve the course of type 1 diabetes. The immune-mediated destruction of beta cells that is an apparent major pathological basis for the disease, has led to efforts to prevent or suppress this immune assault. Here the investigators propose to buttress the beta cell's capacity to withstand this assault by improving the function of the endoplasmic reticulum stress resolving mechanisms within these cells. The ability to do so could have a major impact on preventive and therapeutic strategies for type 1 diabetes (and possibly other types of diabetes). The type of endoplasmic reticulum stress relieving agent (TUDCA) proposed here could ultimately be applied on an anticipatory basis to individuals at high risk for type 1 diabetes.
Key facts
- Study ID
- NCT02218619
- Run by
- Robin Goland, MD
- People needed
- 20
- Starts
- 2015-08-01
- Expected to finish
- 2019-12-31
- Last updated by the study team
- 2025-06-05
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Type 1 diabetes according to American Diabetes Association criteria
- Diagnosis of type 1 diabetes within 100 days of randomization
- One positive diabetes-related autoantibody
- Ages 18-45 years
You may not qualify if…
- Drugs known to affect glucose other than insulin
- Stimulated C-peptide levels < 0.2 pmol/ml measured during a mixed meal tolerance test conducted at least 21 days from diagnosis of diabetes and within one month (37 days) of randomization to either TUDCA or placebo.
- Women during pregnancy
Where it is running
- Naomi Berrie Diabetes Center, Columbia University, 1150 St. Nicholas Ave. — New York, New York, United States
Full record on ClinicalTrials.gov
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