Diabetes Mellitus, Type 2DIAB-EETsNCT02311075
Mechanisms of Endothelial Dysfunction in Type 2 Diabetes
A study testing Blood samples in people with Diabetes Mellitus, Type 2, run by University Hospital, Rouen at 1 site in France.
Trial summary
Endothelial dysfunction of conduit arteries plays an important role in the development of cardiovascular complications associated with type 2 diabetes. In order to propose targeted therapeutic approaches, this study aim to determine the mechanisms involved in endothelial dysfunction of conduit arteries in these… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients or control subjects or healthy volunteers
Who cannot join
- Macroangiopathy
- Insulin treatment
- Chronic kidney disease (eGFR<60 ml/min/m²)
- Hyperlipidemia (total cholesterol>2.5 g/l)
- Smoking habit > 5 cigarettes/day
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Mechanisms Involved in Conduit Artery Endothelial Dysfunction in Type 2 Diabetes
Endothelial dysfunction of conduit arteries plays an important role in the development of cardiovascular complications associated with type 2 diabetes. In order to propose targeted therapeutic approaches, this study aim to determine the mechanisms involved in endothelial dysfunction of conduit arteries in these patients.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Blood samples
- 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.
Blood samplesBiological
Blood samples will be performed at baseline and during endothelial stimulation by hand skin heating to quantify metabolites of NO, EETs, ET-1 and ROS
| Study group | Role | What they receive |
|---|---|---|
| Patient comparative approach | Experimental | Assessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples. Receives: Biological: Blood samples |
| Control subjects comparative approach | Experimental | Assessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples. Receives: Biological: Blood samples |
| Healthy volunteers metabolic approach | Experimental | Assessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples during hyperglycemia or hyperinsulinemia. Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in EET concentration during endothelial stimulation
Measured: 30 min from the beginning of hand skin heating
Secondary outcomes (3)
Change from Baseline in NO concentration during endothelial stimulation
Measured: 30 min from the beginning of hand skin heating
Change from Baseline in ET-1 concentration during endothelial stimulation
Measured: 30 min from the beginning of hand skin heating
Change from Baseline in ROS concentration during endothelial stimulation
Measured: 30 min from the beginning of hand skin heating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016
- Study completionDec 2016
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robinson JOANNIDES, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311075
- Sponsor's protocol ID
- 2013/049/HP
- Other IDs
- 2013-A01107-38
- Acronym
- DIAB-EETs
- Status last verified
- Jun 2017
- First submitted
- 25 Nov 2014
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Duflot T, Moreau-Grange L, Roche C, Iacob M, Wils J, Remy-Jouet I, Cailleux AF, Leuillier M, Renet S, Li D, Morisseau C, Lamoureux F, Richard V, Prevost G, Joannides R, Bellien J. Altered bioavailability of epoxyeicosatrienoic acids is associated with conduit artery endothelial dysfunction in type 2 diabetic patients. Cardiovasc Diabetol. 2019 Mar 18;18(1):35. doi: 10.1186/s12933-019-0843-z.
PubMed 30885203
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Mechanisms Involved in Conduit Artery Endothelial Dysfunction in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02311075
- Acronym / sponsor ID
- DIAB-EETs / 2013/049/HP
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Dec 2014 (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.
Endothelial dysfunction of conduit arteries plays an important role in the development of cardiovascular complications associated with type 2 diabetes. In order to propose targeted therapeutic approaches, this study aim to determine the mechanisms involved in endothelial dysfunction of conduit arteries in these patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient comparative approach | Experimental | Biological: Blood samplesAssessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples. |
| Control subjects comparative approach | Experimental | Biological: Blood samplesAssessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples. |
| Healthy volunteers metabolic approach | Experimental | Biological: Blood samplesAssessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples during hyperglycemia or hyperinsulinemia. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetic patients or control subjects or healthy volunteers
Key exclusion criteria (6 listed)
- Macroangiopathy
- Insulin treatment
- Chronic kidney disease (eGFR<60 ml/min/m²)
- Hyperlipidemia (total cholesterol>2.5 g/l)
- Smoking habit > 5 cigarettes/day
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 |
|---|---|---|
| Blood samplesBlood samples will be performed at baseline and during endothelial stimulation by hand skin heating to quantify metabolites of NO, EETs, ET-1 and ROS | Biological | Control subjects comparative approach, Healthy volunteers metabolic approach, Patient comparative approach |
Primary outcome
Change from Baseline in EET concentration during endothelial stimulation
Time frame: 30 min from the beginning of hand skin heating
3 secondary outcomes
Change from Baseline in NO concentration during endothelial stimulation
Time frame: 30 min from the beginning of hand skin heating
Change from Baseline in ET-1 concentration during endothelial stimulation
Time frame: 30 min from the beginning of hand skin heating
Change from Baseline in ROS concentration during endothelial stimulation
Time frame: 30 min from the beginning of hand skin heating
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 14 Jun 2017.
- Derived from this study: PubMed 30885203Duflot T, Moreau-Grange L, Roche C, Iacob M, Wils J, Remy-Jouet I, Cailleux AF, Leuillier M, Renet S, Li D, Morisseau C, Lamoureux F, Richard V, Prevost G, Joannides R, Bellien J. Altered bioavailability of epoxyeicosatrienoic acids is associated with conduit artery endothelial dysfunction in type 2 diabetic patients. Cardiovasc Diabetol. 2019 Mar 18;18(1):35. doi: 10.1186/s12933-019-0843-z.
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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.
Robinson JOANNIDES, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Diabetes Mellitus, Type 2, run by University Hospital, Rouen at 1 site in France.
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 1 inclusion and 6 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 14 Jun 2017. 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 France. 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 EET concentration during endothelial stimulation (time frame: 30 min from the beginning of hand skin heating). 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 NCT02311075, 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 14 Jun 2017; AzTrials last refreshed its copy on 2 Nov 2026.