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Completed

NCT Number: NCT03331432

Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tauroursodeoxycholic acid

Dietary Supplement

Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks.

Placebo

Dietary Supplement

Taking daily placebo capsules for 4 weeks.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Nov 6, 2017
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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