Status:
TERMINATED
Effects of TUDCA on Endothelial Function in Type 2 DM
Lead Sponsor:
Boston University
Conditions:
Diabetes Mellitus, Type 2
Insulin Response
Eligibility:
All Genders
21-75 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03462940
Start Date
April 2 2018
End Date
February 9 2021
Last Update
March 24 2021
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118