Effects of TUDCA on Endothelial Function in Type 2 DM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-02

Study Completion Date

2021-02-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2 Insulin Response Endothelial Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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TUDCA Group

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).

Group Type EXPERIMENTAL

Tauroursodeoxycholic acid

Intervention Type DIETARY_SUPPLEMENT

Tauroursodeoxycholic acid is an ambiphilic bile acid. It is the taurine conjugate form of ursodeoxycholic acid.

Interventions

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Tauroursodeoxycholic acid

Tauroursodeoxycholic acid is an ambiphilic bile acid. It is the taurine conjugate form of ursodeoxycholic acid.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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TUDCA

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No