Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Tauroursodeoxycholic acid

• Registration Number: NCT03331432
• Lead Sponsor: University of Missouri-Columbia

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.

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 Timeline

• Study Start: 2015-10-28
• Primary Completion: 2017-08-15
• Status Verified: 2017-10
• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-06
• Study Completion: 2018-02-14
• Last Update Submitted: 2018-02-14
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Taking daily placebo capsules for 4 weeks
Tauroursodeoxycholic acid	Tauroursodeoxycholic acid	Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks

Primary Outcome Measures

Name	Time	Method
Blood flow	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
Insulin resistance	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
Glucose tolerance	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
Vascular function	Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid	Flow-mediated dilation

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States