Effects of TUDCA on Endothelial Function in Type 2 DM

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03462940
• Other study ID #: H-35009
• Status: Terminated
• Phase: N/A
• Start date: April 2, 2018
• Est. completion date: February 9, 2021

Study information

• Verified date: March 2021
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 9, 2021
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus defined as fasting glucose greater than or equal to 120 mg/dL, HgA1C =6.5% or ongoing treatment with hypoglycemic medication.
• Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.

Exclusion Criteria:

• Women lactating or pregnant. All women with childbearing potential will undergo a urine pregnancy test at each visit to exclude pregnancy.
• Treatment with an investigational product within the last 30 days.
• Clinically evident major illness of other organ systems, including end-stage cancer, renal failure, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
• Inability to provide informed consent.
• Clinical instability that would preclude withholding medications as determined by the study physician.

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Tauroursodeoxycholic acid
Tauroursodeoxycholic acid is an ambiphilic bile acid. It is the taurine conjugate form of ursodeoxycholic acid.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Secondary	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.	before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Secondary	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	before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Secondary	Change in fasting glucose	The blood sample will be processed to measure fasting glucose levels	before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Secondary	Change in insulin levels	The blood sample will be processed to measure insulin levels	before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Secondary	Change in lipid levels	The blood sample will be processed to measure lipids levels including total cholesterol, LDL, HDL and triglycerides	before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period