Diabetes MellitusNCT01881347
Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus
A study testing Resveratrol in people with Diabetes Mellitus, run by Boston University at 1 site in United States.
Trial summary
The present study is designed to test the hypothesis that resveratrol supplementation will improve the function of the endothelium in patients with type 2 diabetes mellitus. The function of the endothelium will be tested with a non-invasive technique that uses ultrasound to measure the amount of dilation that occurs… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Resveratrol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2013to Jul 2016
- 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
- Male and female subjects
- Age over 21 years old
- Body mass index less than 38 kg/m2
- Clinical stable type 2 diabetes mellitus
Who cannot join
- Women who are lactating or pregnant
- Treatment with an investigations product within 30 days of screening
- Clinically evident major illness of other organ systems, including cancer, renal failure, or other conditions in the opinion of the investigators that would make clinical study inappropriate
- Liver transaminase levels greater than 3 times the upper limit of normal
- History of psychological illness or condition that would interfere with the subject's ability to understand the requirements of the study
- Vitamin supplements exceeding two times the recommended daily allowance
- Resveratrol or other dietary supplements except for a daily multivitamin
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Randomized Crossover Study of The Effects of Resveratrol on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
The present study is designed to test the hypothesis that resveratrol supplementation will improve the function of the endothelium in patients with type 2 diabetes mellitus.
The function of the endothelium will be tested with a non-invasive technique that uses ultrasound to measure the amount of dilation that occurs in the brachial artery following 5-minute cuff occlusion. To help us understand potential mechanisms of benefit, we will also collect blood, urine, and cell samples and test the effects of treatment on protein expression, nitric oxide production, and function of mitochondria.
- Conditions
- Diabetes Mellitus
- Being tested
- Resveratrol, Placebo
- Keywords
- endothelium, mitochondria, reactive oxygen species, vascular biology, arterial stiffness, nitric oxide
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
Resveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks.
PlaceboDietary supplement
Placebo 100 mg daily for 2 weeks followed by placebo 300 mg daily for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active First | Experimental | Active resveratrol first, placebo second Receives: Dietary Supplement: Resveratrol; Dietary Supplement: Placebo |
| Placebo first | Experimental | Placebo first, active resveratrol second Receives: Dietary Supplement: Resveratrol; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Brachial artery flow mediated dilation
Measured: 2 hours, 2 weeks, and 4 weeks
Secondary outcomes (3)
Change from Baseline in Fingertip peripheral arterial tonometry
Measured: 2 hours, 2 weeks, and 4 weeks
Change from Baseline in Carotid femoral pulse wave velocity
Measured: 4 weeks
Change from Baseline in Reactive hyperemia
Measured: 2 hours, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study start1 Jan 2013
- Primary completion1 Mar 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Naomi Hamburg, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881347
- Sponsor's protocol ID
- H-32036
- Other IDs
- 5P01HL068758-10
- Status last verified
- Feb 2018
- First submitted
- 14 Jun 2013
- Last updated
- 1 Mar 2018
- 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 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Crossover Study of The Effects of Resveratrol on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01881347
- Acronym / sponsor ID
- H-32036
- Conditions
- Diabetes Mellitus
- Keywords
- endothelium, mitochondria, reactive oxygen species, vascular biology, arterial stiffness, nitric oxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Mar 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 Jun 2013 (estimated)
- 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 present study is designed to test the hypothesis that resveratrol supplementation will improve the function of the endothelium in patients with type 2 diabetes mellitus.
The function of the endothelium will be tested with a non-invasive technique that uses ultrasound to measure the amount of dilation that occurs in the brachial artery following 5-minute cuff occlusion. To help us understand potential mechanisms of benefit, we will also collect blood, urine, and cell samples and test the effects of treatment on protein expression, nitric oxide production, and function of mitochondria.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active First | Experimental | Dietary Supplement: Resveratrol, Dietary Supplement: PlaceboActive resveratrol first, placebo second |
| Placebo first | Experimental | Dietary Supplement: Resveratrol, Dietary Supplement: PlaceboPlacebo first, active resveratrol second |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects
- Age over 21 years old
- Body mass index less than 38 kg/m2
- Clinical stable type 2 diabetes mellitus
Key exclusion criteria (7 listed)
- Women who are lactating or pregnant
- Treatment with an investigations product within 30 days of screening
- Clinically evident major illness of other organ systems, including cancer, renal failure, or other conditions in the opinion of the investigators that would make clinical study inappropriate
- Liver transaminase levels greater than 3 times the upper limit of normal
- History of psychological illness or condition that would interfere with the subject's ability to understand the requirements of the study
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 |
|---|---|---|
| ResveratrolResveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks. | Dietary supplement | Active First, Placebo first |
| PlaceboPlacebo 100 mg daily for 2 weeks followed by placebo 300 mg daily for 2 weeks. | Dietary supplement | Active First, Placebo first |
Primary outcome
Change from baseline in Brachial artery flow mediated dilation
Time frame: 2 hours, 2 weeks, and 4 weeks
3 secondary outcomes
Change from Baseline in Fingertip peripheral arterial tonometry
Time frame: 2 hours, 2 weeks, and 4 weeks
Change from Baseline in Carotid femoral pulse wave velocity
Time frame: 4 weeks
Change from Baseline in Reactive hyperemia
Time frame: 2 hours, 2 weeks, 4 weeks
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 1 Mar 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.
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 Resveratrol in people with Diabetes Mellitus, 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 4 inclusion and 7 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 1 Mar 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. 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?
Change from baseline in Brachial artery flow mediated dilation (time frame: 2 hours, 2 weeks, and 4 weeks). 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 1 Mar 2018.