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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-A0109552 | Other Identifier | Eudra CT |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trinitrin | Drug | Trinitrin: 2 sublingual pulverisations of 0.3 mg/dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the presence of a retinal endothelial dysfunction in patients with type 1 diabetes mellitus with Dynamic vessel analyser(assessment study visit) | up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of a peripheral endothelial dysfunction | up to 4 months | |
| Correlation between retinal and peripheral endothelial dysfunction (assessment study visit) | up to 4 months | |
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Inclusion Criteria:
For diabetic patients :
For control subjects :
For both diabetic patients and control subjects :
Exclusion Criteria:
For both diabetic patients and control subjects :
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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
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| Name | Affiliation | Role |
|---|---|---|
| Amélie LECLEIRE-COLLET, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Pascale MASSIN, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital LARIBOISIERE Service d'Ophtalmologie | Paris | 75010 | France |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| D010656 | Phenylephrine |
| D007478 | Iontophoresis |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
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| Neosynephrine 10% collyrium | Drug | Neosynephrine 10% collyrium: 2 drops |
|
| Iontophoresis with acetylcholine delivery | Drug | Iontophoresis with acetylcholine delivery |
|
| Dynamic Vessel Analyzer | Device | Dynamic Vessel Analyzer |
|
| Serum concentration of: CRP, ICAM-1, VCAM-1, VEGF, angiopoietin 2 and endostatin. |
| up to 4 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D000438 |
| Alcohols |
| D000588 | Amines |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D004586 | Electrophoresis |
| D055664 | Electrochemical Techniques |
| D008919 | Investigative Techniques |