Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function

Study Overview
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Tauroursodeoxycholic acid
* Dietary Supplement: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Single-blinded randomized crossover study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Taking daily placebo capsules for 4 weeks | Dietary Supplement: Placebo<br>* Taking daily placebo capsules for 4 weeks.<br>|
| Experimental: Tauroursodeoxycholic acid<br>Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks | Dietary Supplement: Tauroursodeoxycholic acid<br>* Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |