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Trial record 3 of 27 for:    TUDCA

Effects of TUDCA on Endothelial Function in Type 2 DM

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: NCT03462940
Recruitment Status : Suspended (Currently suspended due to covid-19 policies.)
First Posted : March 13, 2018
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Boston University

Brief Summary:
The pilot study is designed to investigate the acute and chronic effects of the diet supplement tauroursodeoxycholic acid (TUDCA) on endothelial function in participants with type 2 diabetes mellitus.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Insulin Response Endothelial Dysfunction Dietary Supplement: Tauroursodeoxycholic acid Not Applicable

Detailed Description:
This is a pilot study designed to investigate the effect of two doses of TUDCA on endothelial function.All subjects will receive 500 mg/day in a one week run-in period and then 1750 mg/day in one week treatment period. The study will consist of four visits (screening visit and three study visits), and last up to 2 weeks for individual subjects, depending on the time between visits. It is estimated that the study will last two years from IRB approval through data analysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pilot Study of The Effects of Tauroursodeoxycholic Acid (TUDCA) on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TUDCA Group
All subjects will receive 500 mg/day in a one week run-in period and then 1750 mg/day in one week treatment period of of the nutritional supplement Tauroursodeoxycholic acid (TUDCA).
Dietary Supplement: Tauroursodeoxycholic acid
Tauroursodeoxycholic acid is an ambiphilic bile acid. It is the taurine conjugate form of ursodeoxycholic acid.
Other Name: TUDCA




Primary Outcome Measures :
  1. Change in vascular function [ Time Frame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period ]
    Endothelium -dependent flow-mediated dilation of the brachial artery by ultrasound and fingertip tonometry at baseline and 5-minute cuff occlusion of the upper arm.


Secondary Outcome Measures :
  1. Change in endoplasmic reticulum stress [ Time Frame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period ]
    Endothelial cells will be collected utilizing a J-wire inserted into an arm vein with an 18 gauge catheter using sterile technique and local anesthesia. ER stress will be measured by the study of early and chronic markers of ER stress activation by western blotting and PCR techniques.

  2. Change in endothelial function [ Time Frame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period ]
    Endothelial cells will be collected utilizing a J-wire inserted into an arm vein with an 18 gauge catheter using sterile technique and local anesthesia. Endothelial function will be measured by the study of endothelial nitric oxide synthase activation and nitric oxide production

  3. Change in fasting glucose [ Time Frame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period ]
    The blood sample will be processed to measure fasting glucose levels

  4. Change in insulin levels [ Time Frame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period ]
    The blood sample will be processed to measure insulin levels

  5. Change in lipid levels [ Time Frame: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period ]
    The blood sample will be processed to measure lipids levels including total cholesterol, LDL, HDL and triglycerides



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus defined as fasting glucose greater than or equal to 120 mg/dL, HgA1C ≥6.5% or ongoing treatment with hypoglycemic medication.
  • Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.

Exclusion Criteria:

  • Women lactating or pregnant. All women with childbearing potential will undergo a urine pregnancy test at each visit to exclude pregnancy.
  • Treatment with an investigational product within the last 30 days.
  • Clinically evident major illness of other organ systems, including end-stage cancer, renal failure, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
  • Inability to provide informed consent.
  • Clinical instability that would preclude withholding medications as determined by the study physician.

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): NCT03462940


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
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Principal Investigator: Naomi Hamburg, MD Boston University Medical Campus
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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT03462940    
Other Study ID Numbers: H-35009
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Boston University:
Tauroursodeoxycholic acid (TUDCA)
Endothelial function in humans
Endoplasmic Reticulum Stress
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Tauroursodeoxycholic acid
Antiviral Agents
Anti-Infective Agents
Cholagogues and Choleretics
Gastrointestinal Agents