NCT03462940

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

April 2, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

2.9 years

First QC Date

February 27, 2018

Last Update Submit

March 20, 2021

Conditions

Diabetes Mellitus, Type 2Insulin ResponseEndothelial Dysfunction

Keywords

Tauroursodeoxycholic acid (TUDCA)Endothelial function in humansEndoplasmic Reticulum Stress

Outcome Measures

Primary Outcomes (1)

  • Change in vascular function

    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.

    before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period

Secondary Outcomes (5)

  • Change in endoplasmic reticulum stress

    before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period

  • Change in endothelial function

    before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period

  • Change in fasting glucose

    before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period

  • Change in insulin levels

    before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period

  • Change in lipid levels

    before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period

Study Arms (1)

TUDCA Group

EXPERIMENTAL

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

Interventions

Tauroursodeoxycholic acidDIETARY_SUPPLEMENT

Tauroursodeoxycholic acid is an ambiphilic bile acid. It is the taurine conjugate form of ursodeoxycholic acid.

Also known as: TUDCA
TUDCA Group

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ursodoxicoltaurine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Naomi Hamburg, MD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 13, 2018

Study Start

April 2, 2018

Primary Completion

February 9, 2021

Study Completion

February 9, 2021

Last Updated

March 24, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)