Clinical trial NCT03462940: Effects of TUDCA on Endothelial Function in Type 2 DM
Official title: Pilot Study of The Effects of Tauroursodeoxycholic Acid (TUDCA) on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Insulin Response
Endothelial Dysfunction
Keywords: Tauroursodeoxycholic acid (TUDCA)
Endothelial function in humans
Endoplasmic Reticulum Stress
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 2
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in vascular function
timeFrame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Secondary outcomes:
measure: Change in endoplasmic reticulum stress
timeFrame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
measure: Change in endothelial function
timeFrame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
measure: Change in fasting glucose
timeFrame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
measure: Change in insulin levels
timeFrame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
measure: Change in lipid levels
timeFrame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Naomi Hamburg, MD
role: PRINCIPAL_INVESTIGATOR
References: