Type 2 Diabetes MellitusNCT03331432
Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function
A study testing Tauroursodeoxycholic acid in people with Type 2 Diabetes Mellitus, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Tauroursodeoxycholic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2015to 14 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes diagnosed by primary physician
- Body mass index less then 43 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting Endoplasmic Reticulum Stress to Correct Vascular Insulin Resistance and Glycemic Dysregulation
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Tauroursodeoxycholic acid, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tauroursodeoxycholic acidDietary supplement
Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks.
PlaceboDietary supplement
Taking daily placebo capsules for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Taking daily placebo capsules for 4 weeks Receives: Dietary Supplement: Placebo |
| Tauroursodeoxycholic acid | Experimental | Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks Receives: Dietary Supplement: Tauroursodeoxycholic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow
Blood flow response during insulin clamp
Measured: 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
Measured: 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
Measured: 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
Measured: Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start28 Oct 2015
- Primary completion15 Aug 2017
- Study completion14 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-blinded randomized crossover study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaume Padilla, University of Missouri-Columbia
- Investigators
- Jaume Padilla, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331432
- Sponsor's protocol ID
- 1203573
- Status last verified
- Oct 2017
- First submitted
- 26 Oct 2017
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Endoplasmic Reticulum Stress to Correct Vascular Insulin Resistance and Glycemic Dysregulation
- ClinicalTrials.gov ID
- NCT03331432
- Acronym / sponsor ID
- 1203573
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 28 Oct 2015 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 14 Feb 2018 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blinded randomized crossover study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTaking daily placebo capsules for 4 weeks |
| Tauroursodeoxycholic acid | Experimental | Dietary Supplement: Tauroursodeoxycholic acidTaking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes diagnosed by primary physician
- Body mass index less then 43 kg/m2
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tauroursodeoxycholic acidTaking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks. | Dietary supplement | Tauroursodeoxycholic acid |
| PlaceboTaking daily placebo capsules for 4 weeks. | Dietary supplement | Placebo |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaume Padilla, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tauroursodeoxycholic acid in people with Type 2 Diabetes Mellitus, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow (time frame: Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.