Type 2 Diabetes MellitusNCT01609088
Pilot Study of the Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus
A study testing Erythritol-containing beverage in people with Type 2 Diabetes Mellitus, run by Boston University at 1 site in United States.
Trial summary
The study will determine whether acute and chronic consumption of a beverage containing erythritol will improve endothelial function in patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Erythritol-containing beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2012
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Otherwise healthy
Who cannot join
- Pregnant
- BMI>35 kg/m2
- Long acting insulin treatment
- Other major illness, drug abuse
- Treatment with an investigational drug within 12 weeks
- Treatment with dietary or vitamin supplements
- Smoking within 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Medicine
Boston, Massachusetts, 02118
About this study
The study will determine whether acute and chronic consumption of a beverage containing erythritol will improve endothelial function in patients with type 2 diabetes mellitus.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Erythritol-containing beverage
- Keywords
- endothelium, diabetes mellitus, oxidative stress
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythritol-containing beverageDietary supplement
Orange flavored beverage containing erythritol
| Study group | Role | What they receive |
|---|---|---|
| Erythritol-containing beverage | Experimental | Not described Receives: Dietary Supplement: Erythritol-containing beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow mediated dilation
Measured: Change from baseline at 28 days
Secondary outcomes (6)
Brachial artery flow-mediated dilation
Reactive hyperemia, carotid femoral pulse wave velocity, fingertip tonometry.
Measured: Change from baseline at 2 hours
Reactive hyperemia
Measured: Change from baseline at 2 hours and 28 days
Carotid femoral pulse wave velocity
Measured: Change from baseline at 28 days
Fingertip tonometry
Measured: Change from baseline at 2 hours and 28 days
Urine F2 isoprostanes
Measured: Change from baseline at 28 days
C-reactive protein
Measured: Change from baseline at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Cargill
- Responsible party
- Principal investigator, Joseph A. Vita, Boston University
- Investigators
- Joseph A. Vita, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609088
- Sponsor's protocol ID
- H-31447
- Status last verified
- Jul 2013
- First submitted
- 25 May 2012
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Flint N, Hamburg NM, Holbrook M, Dorsey PG, LeLeiko RM, Berger A, de Cock P, Bosscher D, Vita JA. Effects of erythritol on endothelial function in patients with type 2 diabetes mellitus: a pilot study. Acta Diabetol. 2014;51(3):513-6. doi: 10.1007/s00592-013-0534-2. Epub 2013 Dec 24.
PubMed 24366423
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01609088
- Acronym / sponsor ID
- H-31447
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- endothelium, diabetes mellitus, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Cargill
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 May 2012 (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 study will determine whether acute and chronic consumption of a beverage containing erythritol will improve endothelial function in patients with type 2 diabetes mellitus.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erythritol-containing beverage | Experimental | Dietary Supplement: Erythritol-containing beverage |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes mellitus
- Otherwise healthy
Key exclusion criteria (7 listed)
- Pregnant
- BMI>35 kg/m2
- Long acting insulin treatment
- Other major illness, drug abuse
- Treatment with an investigational drug within 12 weeks
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 |
|---|---|---|
| Erythritol-containing beverageOrange flavored beverage containing erythritol | Dietary supplement | Erythritol-containing beverage |
Primary outcome
Brachial artery flow mediated dilation
Time frame: Change from baseline at 28 days
6 secondary outcomes
Brachial artery flow-mediated dilation
Time frame: Change from baseline at 2 hours
Reactive hyperemia
Time frame: Change from baseline at 2 hours and 28 days
Carotid femoral pulse wave velocity
Time frame: Change from baseline at 28 days
Fingertip tonometry
Time frame: Change from baseline at 2 hours and 28 days
Urine F2 isoprostanes
Time frame: Change from baseline at 28 days
C-reactive protein
Time frame: Change from baseline at 28 days
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 24 Jul 2013.
- Derived from this study: PubMed 24366423Flint N, Hamburg NM, Holbrook M, Dorsey PG, LeLeiko RM, Berger A, de Cock P, Bosscher D, Vita JA. Effects of erythritol on endothelial function in patients with type 2 diabetes mellitus: a pilot study. Acta Diabetol. 2014;51(3):513-6. doi: 10.1007/s00592-013-0534-2. Epub 2013 Dec 24.
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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.
Joseph A. Vita, 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 Erythritol-containing beverage in people with Type 2 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 2 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 24 Jul 2013. 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?
Brachial artery flow mediated dilation (time frame: Change from baseline at 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01609088, which also lists 1 linked publication.
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 Jul 2013.