Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03331432
• Other study ID #: 1203573
• Status: Completed
• Phase: N/A
• First received: October 26, 2017
• Last updated: February 14, 2018
• Start date: October 28, 2015
• Est. completion date: February 14, 2018

Study information

• Verified date: October 2017
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 14, 2018
• Est. primary completion date: August 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Tauroursodeoxycholic acid
Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks.
• Placebo
Taking daily placebo capsules for 4 weeks.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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