Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function

NCT ID: NCT03331432

Last Updated: 2018-02-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-28

Study Completion Date

2018-02-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Single-blinded randomized crossover study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants are not told which are placebo or tauroursodeoxycholic acid capsules

Study Groups

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Placebo

Taking daily placebo capsules for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Taking daily placebo capsules for 4 weeks.

Tauroursodeoxycholic acid

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

Group Type EXPERIMENTAL

Tauroursodeoxycholic acid

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Tauroursodeoxycholic acid

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Taking daily placebo capsules for 4 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Jaume Padilla

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaume Padilla, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

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University of Missouri

Columbia, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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1203573

Identifier Type: -

Identifier Source: org_study_id

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