Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function

University of Missouri (MU)

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: Tauroursodeoxycholic acid; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03331432

1203573

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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8 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Taking daily placebo capsules for 4 weeks

Treatment:

Dietary Supplement: Placebo

Tauroursodeoxycholic acid

Experimental group

Description:

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

Treatment:

Dietary Supplement: Tauroursodeoxycholic acid