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Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331432
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Jaume Padilla, 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dietary Supplement: Tauroursodeoxycholic acid Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single-blinded randomized crossover study
Masking: Single (Participant)
Masking Description: Participants are not told which are placebo or tauroursodeoxycholic acid capsules
Primary Purpose: Basic Science
Official Title: Targeting Endoplasmic Reticulum Stress to Correct Vascular Insulin Resistance and Glycemic Dysregulation
Actual Study Start Date : October 28, 2015
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : February 14, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Taking daily placebo capsules for 4 weeks
Dietary Supplement: Placebo
Taking daily placebo capsules for 4 weeks.

Experimental: Tauroursodeoxycholic acid
Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks
Dietary Supplement: Tauroursodeoxycholic acid
Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks.




Primary Outcome Measures :
  1. Blood flow [ Time Frame: 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

  2. Vascular function [ Time Frame: Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid ]
    Flow-mediated dilation

  3. Insulin resistance [ Time Frame: 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

  4. Glucose tolerance [ Time Frame: 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



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331432


Locations
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United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65211
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Jaume Padilla, PhD University of Missouri-Columbia
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Responsible Party: Jaume Padilla, Assistant Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03331432    
Other Study ID Numbers: 1203573
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Tauroursodeoxycholic acid
Antiviral Agents
Anti-Infective Agents
Cholagogues and Choleretics
Gastrointestinal Agents