Tauroursodeoxycholic Acid (TUDCA) in New-Onset Type 1 Diabetes

• Status: Unknown status
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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 we 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Robin Goland, MD
• Collaborator: Juvenile Diabetes Research Foundation
• Treatments: Taurochenodeoxycholic Acid; Tauroursodeoxycholic acid; Ursodoxicoltaurine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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