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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
2
Tauroursodeoxycholic acid is an ambiphilic bile acid. It is the taurine conjugate form of ursodeoxycholic acid.
Boston Medical Center
Boston, Massachusetts, United States
Change in vascular function
Endothelium -dependent flow-mediated dilation of the brachial artery by ultrasound and fingertip tonometry at baseline and 5-minute cuff occlusion of the upper arm.
Time frame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Change in endoplasmic reticulum stress
Endothelial cells will be collected utilizing a J-wire inserted into an arm vein with an 18 gauge catheter using sterile technique and local anesthesia. ER stress will be measured by the study of early and chronic markers of ER stress activation by western blotting and PCR techniques.
Time frame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Change in endothelial function
Endothelial cells will be collected utilizing a J-wire inserted into an arm vein with an 18 gauge catheter using sterile technique and local anesthesia. Endothelial function will be measured by the study of endothelial nitric oxide synthase activation and nitric oxide production
Time frame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Change in fasting glucose
The blood sample will be processed to measure fasting glucose levels
Time frame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Change in insulin levels
The blood sample will be processed to measure insulin levels
Time frame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Change in lipid levels
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The blood sample will be processed to measure lipids levels including total cholesterol, LDL, HDL and triglycerides
Time frame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period