Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function

February 14, 2018 updated by: Jaume Padilla, University of Missouri-Columbia

Targeting Endoplasmic Reticulum Stress to Correct Vascular Insulin Resistance and Glycemic Dysregulation

The purpose of the present study is to determine if use of dietary supplement tauroursodeoxycholic acid enhances insulin-stimulated leg blood flow and glucose disposal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The notion that cellular stress lowers insulin-induced vasodilation is largely founded on ex vivo studies and experiments in rodents. However, it remains unknown if maintenance of cellular function with the use of dietary supplement tauroursodeoxycholic acid enhances vascular function in humans. The investigators test the hypothesis that daily administration of this dietary supplement enhances vascular function, particularly, insulin-stimulated leg blood flow and glucose disposal.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes diagnosed by primary physician
  • Body mass index less then 43 kg/m2

Exclusion Criteria:

  • Recent weight gain or loss (>5% body weight in the last 3 months)
  • Pregnancy
  • Consumption of >14 alcoholic beverages per week
  • Changes in the medication use or dose within the last 3 months
  • Known cardiovascular or pulmonary disease
  • Taking medication for advanced retinopathy or neuropathy
  • Taking prescription anticoagulants
  • Nicotine use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Taking daily placebo capsules for 4 weeks
Dietary supplement: Placebo
Taking daily placebo capsules for 4 weeks.
Experimental: Tauroursodeoxycholic acid
Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks
Dietary supplement: Tauroursodeoxycholic acid
Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood flow
Time Frame: Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid
Blood flow response during insulin clamp
Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid
Vascular function
Time Frame: Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid
Flow-mediated dilation
Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid
Insulin resistance
Time Frame: Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid
Glucose disposal rate during insulin clamp
Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid
Glucose tolerance
Time Frame: Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid
Glucose response to an oral glucose tolerance test
Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Jaume Padilla, PhD, University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2015

Primary Completion (Actual)

August 15, 2017

Study Completion (Actual)

February 14, 2018

Study Registration Dates

First Submitted

October 26, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1203573

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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