Back to resultsEffects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tauroursodeoxycholic acid
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- University of Missouri
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Tauroursodeoxycholic acid
Arm Description
Taking daily placebo capsules for 4 weeks
Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks
Outcomes
Primary Outcome Measures
Blood flow
Blood flow response during insulin clamp
Vascular function
Flow-mediated dilation
Insulin resistance
Glucose disposal rate during insulin clamp
Glucose tolerance
Glucose response to an oral glucose tolerance test
Secondary Outcome Measures
Full Information
NCT ID
NCT03331432
First Posted
October 26, 2017
Last Updated
February 14, 2018
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT03331432
Brief Title
Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function
Official Title
Targeting Endoplasmic Reticulum Stress to Correct Vascular Insulin Resistance and Glycemic Dysregulation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 28, 2015 (Actual)
Primary Completion Date
August 15, 2017 (Actual)
Study Completion Date
February 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single-blinded randomized crossover study
Masking
Participant
Masking Description
Participants are not told which are placebo or tauroursodeoxycholic acid capsules
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Taking daily placebo capsules for 4 weeks
Arm Title
Tauroursodeoxycholic acid
Arm Type
Experimental
Arm Description
Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Tauroursodeoxycholic acid
Intervention Description
Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Taking daily placebo capsules for 4 weeks.
Primary Outcome Measure Information:
Title
Blood flow
Description
Blood flow response during insulin clamp
Time Frame
Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid
Title
Vascular function
Description
Flow-mediated dilation
Time Frame
Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid
Title
Insulin resistance
Description
Glucose disposal rate during insulin clamp
Time Frame
Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid
Title
Glucose tolerance
Description
Glucose response to an oral glucose tolerance test
Time Frame
Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaume Padilla, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function
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