NCT03462940

Effects of TUDCA on Endothelial Function in Type 2 DM

Pilot Study of The Effects of Tauroursodeoxycholic Acid (TUDCA) on Endothelial Function in Subjects With Type 2 Diabetes Mellitus

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The pilot study is designed to investigate the acute and chronic effects of the diet supplement tauroursodeoxycholic acid (TUDCA) on endothelial function in participants with type 2 diabetes mellitus.

Detailed description

This is a pilot study designed to investigate the effect of two doses of TUDCA on endothelial function.All subjects will receive 500 mg/day in a one week run-in period and then 1750 mg/day in one week treatment period. The study will consist of four visits (screening visit and three study visits), and last up to 2 weeks for individual subjects, depending on the time between visits. It is estimated that the study will last two years from IRB approval through data analysis.

Conditions

• Diabetes Mellitus, Type 2
• Insulin Response
• Endothelial Dysfunction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Tauroursodeoxycholic acid	Tauroursodeoxycholic acid is an ambiphilic bile acid. It is the taurine conjugate form of ursodeoxycholic acid.

Timeline

• Start date: 2018-04-02
• Primary completion: 2021-02-09
• Completion: 2021-02-09
• First posted: 2018-03-13
• Last updated: 2021-03-24

Locations

1 site across 1 country: United States