Type 1 Diabetes MellitusDENDINCT01097551
Endothelial Dysfunction and Diabetes
An observational study of Type 1 Diabetes Mellitus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the study is to progress in the understanding of the early retinal vascular and neural abnormalities in patients with diabetes, using a new device, the Dynamic Vessel Analyzer. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Trinitrin, Neosynephrine 10% collyrium and Iontophoresis with acetylcholine delivery
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Jul 2011
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with type 1 diabetes: Diabetes duration >= 5 years, age >= 18 and <= 60 years old, patients with no visible diabetic retinopathy, and no arterial hypertension Healthy subjects: Sex and age-matched control healthy subjects
Who may be able to join
- For diabetic patients :
- age between 20 and 60
- type 1 diabetes mellitus
- diabetes duration of more than 5 years
- no diabetic retinopathy on fundus examination or fundus photographs
- no systemic hypertension (defined as systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
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- For control subjects :
- sex and age matching with the diabetic patients
- no diabetes, no familial or personal history of elevated blood sugar
- Non-diabetic subjects, criteria defined by a fasting glucose <1.10 g / l and an HbA1c <6.5% (according to Lariboisière biochemistry laboratory HbA1c)
- no systemic hypertension (defined as systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
- Subject with a normal ophthalmologic examination
- For both diabetic patients and control subjects :
- Subject that has signed informed consent
- Subject affiliated to a social security
- Subject available for a period of 4 months
Who cannot join
- For both diabetic patients and control subjects :
- presence of cataract or history of cataract surgery
- intraocular pressure of more than 21 mmHg
- treatment with vasoactive drugs
- tobacco consumption of more than 20 cigarettes a day
- Contraindications to trinitrin administration: hypersensitivity to trinitrin, treatment by sildenafil, heart disease, severe arterial hypotension, bradycardia, intracranial hypertension
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- Clinical Raynaud syndrome
- Pregnant or breast-feeding subject
- Subject whose age is <18 and> 60 years on the day of inclusion
- Subject with cardiac disease, severe hypotension (BP <80/50 mmHg), a resting heart rate below 50 beats / minute
- Subject intracranial hypertension
- Subject with a current consumption of drugs or drugs that may impact vasomotion (antiglaucoma eye drops, vasodilators, antihypertensive drugs). Vasoactive drug use will be prohibited within 24 hours preceding the study.
- Subject has not signed an informed consent
- Subject not affiliated to a social security
- Subject not available for a period of 4 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Endothelial Dysfunction in Retinal and Peripheral Retinal Vessels in Diabetes
The aim of the study is to progress in the understanding of the early retinal vascular and neural abnormalities in patients with diabetes, using a new device, the Dynamic Vessel Analyzer. The Dynamic Vessel Analyzer allows to measure the diameter of the retinal vessels and to assess how it varies in presence of various stimuli. Then, we will be able to assess if a vascular and/or a neural dysfunction is present early in patient with diabetes.
Read the detailed description
Twenty patients with type 1 diabetes without diabetic retinopathy and without arterial hypertension will be compared with 20 sex and aged-matched healthy control subjects. To assess the presence of retinal endothelial dysfunction, the variations of the diameters of the retinal vessels will be assessed using the Dynamic Vessel Analyzer, before and after flicker light stimulation, sublingual nitroglycerin, neosynephrine eyedrops, and isometric contraction. To assess the presence of peripheral endothelial dysfunction, the microcirculation of the forearm skin will be studied using iontophoresis with acetylcholine delivery, and heat delivery, both coupled with blood flow measurement using laser Doppler. An intravital capillaroscopy of the phalanx skin will be performed. The serum levels of CRP, ICAM-1, VCAM-1, VEGF, angiopoietin 2 and endostatin will also be measured.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Trinitrin, Neosynephrine 10% collyrium, Iontophoresis with acetylcholine delivery, Dynamic Vessel Analyzer
- Keywords
- Type 1 diabetes mellitus, Diabetic retinopathy, Pathogenesis, Dynamic Vessel Analyser, Endothelial dysfunction
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrinitrinDrug
Trinitrin: 2 sublingual pulverisations of 0.3 mg/dose
Neosynephrine 10% collyriumDrug
Neosynephrine 10% collyrium: 2 drops
Iontophoresis with acetylcholine deliveryDrug
Iontophoresis with acetylcholine delivery
Dynamic Vessel AnalyzerDevice
Dynamic Vessel Analyzer
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 1 diabetes | Diabetes duration >= 5 years, age >= 18 and <= 60 years old, patients with no visible diabetic retinopathy, and no arterial hypertension Receives: Drug: Trinitrin; Drug: Neosynephrine 10% collyrium; Drug: Iontophoresis with acetylcholine delivery; Device: Dynamic Vessel Analyzer | |
| Healthy subjects | Sex and age-matched control healthy subjects Receives: Drug: Trinitrin; Drug: Neosynephrine 10% collyrium; Drug: Iontophoresis with acetylcholine delivery; Device: Dynamic Vessel Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the presence of a retinal endothelial dysfunction in patients with type 1 diabetes mellitus with Dynamic vessel analyser(assessment study visit)
Measured: up to 4 months
Secondary outcomes (3)
Presence of a peripheral endothelial dysfunction
Measured: up to 4 months
Correlation between retinal and peripheral endothelial dysfunction (assessment study visit)
Measured: up to 4 months
Serum concentration of: CRP, ICAM-1, VCAM-1, VEGF, angiopoietin 2 and endostatin.
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amélie LECLEIRE-COLLET, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisPascale MASSIN, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097551
- Sponsor's protocol ID
- P080608
- Other IDs
- 2009-A0109552
- Acronym
- DENDI
- Status last verified
- Jul 2012
- First submitted
- 31 Mar 2010
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Endothelial Dysfunction in Retinal and Peripheral Retinal Vessels in Diabetes
- ClinicalTrials.gov ID
- NCT01097551
- Acronym / sponsor ID
- DENDI / P080608
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes mellitus, Diabetic retinopathy, Pathogenesis, Dynamic Vessel Analyser, Endothelial dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 1 Apr 2010 (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 aim of the study is to progress in the understanding of the early retinal vascular and neural abnormalities in patients with diabetes, using a new device, the Dynamic Vessel Analyzer. The Dynamic Vessel Analyzer allows to measure the diameter of the retinal vessels and to assess how it varies in presence of various stimuli. Then, we will be able to assess if a vascular and/or a neural dysfunction is present early in patient with diabetes.
Detailed description
Twenty patients with type 1 diabetes without diabetic retinopathy and without arterial hypertension will be compared with 20 sex and aged-matched healthy control subjects. To assess the presence of retinal endothelial dysfunction, the variations of the diameters of the retinal vessels will be assessed using the Dynamic Vessel Analyzer, before and after flicker light stimulation, sublingual nitroglycerin, neosynephrine eyedrops, and isometric contraction. To assess the presence of peripheral endothelial dysfunction, the microcirculation of the forearm skin will be studied using iontophoresis with acetylcholine delivery, and heat delivery, both coupled with blood flow measurement using laser Doppler. An intravital capillaroscopy of the phalanx skin will be performed. The serum levels of CRP, ICAM-1, VCAM-1, VEGF, angiopoietin 2 and endostatin will also be measured.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with type 1 diabetes | – | Drug: Trinitrin, Drug: Neosynephrine 10% collyrium, Drug: Iontophoresis with acetylcholine delivery, Device: Dynamic Vessel AnalyzerDiabetes duration >= 5 years, age >= 18 and <= 60 years old, patients with no visible diabetic retinopathy, and no arterial hypertension |
| Healthy subjects | – | Drug: Trinitrin, Drug: Neosynephrine 10% collyrium, Drug: Iontophoresis with acetylcholine delivery, Device: Dynamic Vessel AnalyzerSex and age-matched control healthy subjects |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with type 1 diabetes: Diabetes duration >= 5 years, age >= 18 and <= 60 years old, patients with no visible diabetic retinopathy, and no arterial hypertension Healthy subjects: Sex and age-matched control healthy subjects
Key inclusion criteria (16 listed)
- For diabetic patients :
- For control subjects :
- For both diabetic patients and control subjects :
Key exclusion criteria (15 listed)
- For both diabetic patients and control subjects :
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 |
|---|---|---|
| TrinitrinTrinitrin: 2 sublingual pulverisations of 0.3 mg/dose | Drug | Healthy subjects, Patients with type 1 diabetes |
| Neosynephrine 10% collyriumNeosynephrine 10% collyrium: 2 drops | Drug | Healthy subjects, Patients with type 1 diabetes |
| Iontophoresis with acetylcholine deliveryIontophoresis with acetylcholine delivery | Drug | Healthy subjects, Patients with type 1 diabetes |
| Dynamic Vessel AnalyzerDynamic Vessel Analyzer | Device | Healthy subjects, Patients with type 1 diabetes |
Primary outcome
Evaluation of the presence of a retinal endothelial dysfunction in patients with type 1 diabetes mellitus with Dynamic vessel analyser(assessment study visit)
Time frame: up to 4 months
3 secondary outcomes
Presence of a peripheral endothelial dysfunction
Time frame: up to 4 months
Correlation between retinal and peripheral endothelial dysfunction (assessment study visit)
Time frame: up to 4 months
Serum concentration of: CRP, ICAM-1, VCAM-1, VEGF, angiopoietin 2 and endostatin.
Time frame: up to 4 months
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 3 Jul 2012.
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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.
Amélie LECLEIRE-COLLET, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Pascale MASSIN, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Assistance Publique - Hôpitaux de Paris 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 16 inclusion and 15 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 3 Jul 2012. 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?
Evaluation of the presence of a retinal endothelial dysfunction in patients with type 1 diabetes mellitus with Dynamic vessel analyser(assessment study visit) (time frame: up to 4 months). 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 3 Jul 2012.