Effects of TUDCA on Endothelial Function in Type 2 DM

Not Applicable

Terminated

• Conditions: Diabetes Mellitus, Type 2; Endothelial Dysfunction; Insulin Response
• Interventions: Dietary Supplement: Tauroursodeoxycholic acid

• Registration Number: NCT03462940
• Lead Sponsor: Boston University

Brief 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.

Study Timeline

• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-03-09
• Study First Posted: 2018-03-13
• Study Start: 2018-04-02
• Primary Completion: 2021-02-09
• Study Completion: 2021-02-09
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-20
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TUDCA Group	Tauroursodeoxycholic acid	All subjects will receive 500 mg/day in a one week run-in period and then 1750 mg/day in one week treatment period of of the nutritional supplement Tauroursodeoxycholic acid (TUDCA).

Primary Outcome Measures

Name	Time	Method
Change in vascular function	before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period	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.

Secondary Outcome Measures

Name	Time	Method
Change in endoplasmic reticulum stress	before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period	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.
Change in fasting glucose	before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period	The blood sample will be processed to measure fasting glucose levels
Change in endothelial function	before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period	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
Change in insulin levels	before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period	The blood sample will be processed to measure insulin levels
Change in lipid levels	before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period	The blood sample will be processed to measure lipids levels including total cholesterol, LDL, HDL and triglycerides

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States