Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function

NCT03331432 | Completed DMC

• 1 other identifier: 1203573
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• Blood flow

  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

  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

  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

  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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Taking daily placebo capsules for 4 weeks

Dietary Supplement: Placebo

Tauroursodeoxycholic acid

EXPERIMENTAL

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

Dietary Supplement: Tauroursodeoxycholic acid

Interventions

Tauroursodeoxycholic acid DIETARY_SUPPLEMENT

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

Tauroursodeoxycholic acid

Placebo DIETARY_SUPPLEMENT

Taking daily placebo capsules for 4 weeks.

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ursodoxicoltaurine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jaume Padilla, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not told which are placebo or tauroursodeoxycholic acid capsules
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single-blinded randomized crossover study

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 6, 2017
• Study Start: October 28, 2015
• Primary Completion: August 15, 2017
• Study Completion: February 14, 2018
• Last Updated: February 19, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)