Diabetes Mellitus, Type 2NCT03462940
Effects of TUDCA on Endothelial Function in Type 2 DM
A study testing Tauroursodeoxycholic acid in people with Diabetes Mellitus, Type 2 and Insulin Response, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin Response, Endothelial Dysfunction
- What is being tested?
- Tauroursodeoxycholic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2018to 9 Feb 2021
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of The Effects of Tauroursodeoxycholic Acid (TUDCA) on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
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.
Read the 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.
- Being tested
- Tauroursodeoxycholic acid
- Keywords
- Tauroursodeoxycholic acid (TUDCA), Endothelial function in humans, Endoplasmic Reticulum Stress
- 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
Also called TUDCA
Tauroursodeoxycholic acid is an ambiphilic bile acid. It is the taurine conjugate form of ursodeoxycholic acid.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: Tauroursodeoxycholic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Change in endothelial function
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
Measured: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Change in fasting glucose
The blood sample will be processed to measure fasting glucose levels
Measured: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Change in insulin levels
The blood sample will be processed to measure insulin levels
Measured: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Change in lipid levels
The blood sample will be processed to measure lipids levels including total cholesterol, LDL, HDL and triglycerides
Measured: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start2 Apr 2018
- Primary completion9 Feb 2021
- Study completion9 Feb 2021
Why it stopped: The study was halted due to low enrollment exacerbated by COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naomi Hamburg, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462940
- Sponsor's protocol ID
- H-35009
- Status last verified
- Mar 2021
- First submitted
- 27 Feb 2018
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of The Effects of Tauroursodeoxycholic Acid (TUDCA) on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03462940
- Acronym / sponsor ID
- H-35009
- Keywords
- Tauroursodeoxycholic acid (TUDCA), Endothelial function in humans, Endoplasmic Reticulum Stress
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was halted due to low enrollment exacerbated by COVID-19.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 9 Feb 2021 (actual)
- Study completion
- 9 Feb 2021 (actual)
- First posted
- 13 Mar 2018 (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 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TUDCA Group | Experimental | Dietary Supplement: Tauroursodeoxycholic acidAll 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). |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 acidAlso: TUDCATauroursodeoxycholic acid is an ambiphilic bile acid. It is the taurine conjugate form of ursodeoxycholic acid. | Dietary supplement | TUDCA Group |
Primary outcome
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
The study was stopped early (reason given: The study was halted due to low enrollment exacerbated by COVID-19.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- 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.
Naomi Hamburg, MD principal investigator
Boston University
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 Diabetes Mellitus, Type 2 and Insulin Response, run by Boston University 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 5 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: stopped early, as of the sponsor's last update on 24 Mar 2021. 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. 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 was stopped early (reason given: The study was halted due to low enrollment exacerbated by COVID-19.). Results are not available in the source record.
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?
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). 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 24 Mar 2021.