Effects of TUDCA on Endothelial Function in Type 2 DM

Boston University

Status: Terminated

Conditions: Endothelial Dysfunction; Insulin Response; Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: Tauroursodeoxycholic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03462940

H-35009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

TUDCA Group

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Tauroursodeoxycholic acid