Type 2 Diabetes MellitusNCT01908348
Dose-Dependent Effects of Erythritol on Endothelial Function in Type 2 Diabetes Mellitus
A study testing Erythritol in people with Type 2 Diabetes Mellitus, run by Boston University at 1 site in United States.
Trial summary
This study is an open-label pilot designed to examine the dose-dependent effects of erythritol, a zero calorie sweetener, on endothelial function. Twenty-four subjects with type 2 diabetes mellitus will make three study visits. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2013to Dec 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female subjects
- Otherwise healthy patients with Type 2 diabetes mellitus as defined by fasting blood glucose >125 mg/dl or with ongoing treatment for Type 2 diabetes mellitus with the exception of insulin.
Who cannot join
- Women with a positive urine pregnancy test
- Body mass index >35 kg/m2
- Current daily long-acting insulin therapy (short acting, insulin as needed is not an exclusion).
- Clinical history of other major illness including cancer, renal failure, hepatic failure, or other conditions that in the judgment of the principal investigator make a clinical study inappropriate.
- Treatment with an investigational drug within the last twelve weeks
- History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
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- Treatment with vitamin E, vitamin C, and beta carotene, lipoic acid, and other food or herbal supplements within 1 month of enrollment. Subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the recommended daily allowance will not be excluded.
- Recent change in diet or level of physical activity that in the judgment of the investigators would be likely to affect endothelial function (to be evaluated on a case by case basis).
- Ongoing illicit drug use or alcohol abuse.
- Sensitivity/intolerance to dietary polyols.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Medicine
Boston, Massachusetts, 02118
About this study
Official title: Pilot Study: Dose Dependent Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus
This study is an open-label pilot designed to examine the dose-dependent effects of erythritol, a zero calorie sweetener, on endothelial function. Twenty-four subjects with type 2 diabetes mellitus will make three study visits. At each visit, the will consume an orange-flavored beverage containing escalating amounts of erythritol (6, 12, and 18 grams). Endothelial function will be assessed before and two hours after beverage consumption. Endothelial function will be measured as the change in pulse amplitude in response to reactive hyperemia measured in the fingertip by peripheral arterial tonometry. The results will be used to plan a randomized, placebo-controlled study.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Erythritol
- Keywords
- Erythritol, Endothelial function
- 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.
ErythritolDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Erythritol | Experimental | Orange-flavored beverage containing 6, 12, or 18 grams of erythritol Receives: Dietary Supplement: Erythritol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Change in pulse amplitude in the fingertip in response to reactive hyperemia measured by peripheral arterial tonometry.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study start18 Jul 2013
- Primary completion1 Dec 2014
- Study completionDec 2016
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.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Cargill
- Responsible party
- Sponsor
- Investigators
- Naomi M Hamburg, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908348
- Sponsor's protocol ID
- H-32353
- Status last verified
- Feb 2018
- First submitted
- 23 Jul 2013
- Last updated
- 28 Feb 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 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Dose Dependent Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01908348
- Acronym / sponsor ID
- H-32353
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Erythritol, Endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Cargill
- Study start
- 18 Jul 2013 (actual)
- Primary completion
- 1 Dec 2014 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Jul 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.
This study is an open-label pilot designed to examine the dose-dependent effects of erythritol, a zero calorie sweetener, on endothelial function. Twenty-four subjects with type 2 diabetes mellitus will make three study visits. At each visit, the will consume an orange-flavored beverage containing escalating amounts of erythritol (6, 12, and 18 grams). Endothelial function will be assessed before and two hours after beverage consumption. Endothelial function will be measured as the change in pulse amplitude in response to reactive hyperemia measured in the fingertip by peripheral arterial tonometry. The results will be used to plan a randomized, placebo-controlled study.
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 | Experimental | Dietary Supplement: ErythritolOrange-flavored beverage containing 6, 12, or 18 grams of erythritol |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and Female subjects
- Otherwise healthy patients with Type 2 diabetes mellitus as defined by fasting blood glucose >125 mg/dl or with ongoing treatment for Type 2 diabetes mellitus with the exception of insulin.
Key exclusion criteria (10 listed)
- Women with a positive urine pregnancy test
- Body mass index >35 kg/m2
- Current daily long-acting insulin therapy (short acting, insulin as needed is not an exclusion).
- Clinical history of other major illness including cancer, renal failure, hepatic failure, or other conditions that in the judgment of the principal investigator make a clinical study inappropriate.
- Treatment with an investigational drug within the last twelve 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 | Dietary supplement | Erythritol |
Primary outcome
Endothelial function
Time frame: 2 hours
Change in pulse amplitude in the fingertip in response to reactive hyperemia measured by peripheral arterial tonometry.
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 28 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.
Naomi M 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 Erythritol 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 10 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 28 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. 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?
Endothelial function (time frame: 2 hours). 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 28 Feb 2018.