Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT01097551
Status:
COMPLETED
Last Update Posted:
2012-07-03
First Post:
2010-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endothelial Dysfunction and Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}, {'id': 'D010656', 'term': 'Phenylephrine'}, {'id': 'D007478', 'term': 'Iontophoresis'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004586', 'term': 'Electrophoresis'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-02', 'studyFirstSubmitDate': '2010-03-31', 'studyFirstSubmitQcDate': '2010-03-31', 'lastUpdatePostDateStruct': {'date': '2012-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the presence of a retinal endothelial dysfunction in patients with type 1 diabetes mellitus with Dynamic vessel analyser(assessment study visit)', 'timeFrame': 'up to 4 months'}], 'secondaryOutcomes': [{'measure': 'Presence of a peripheral endothelial dysfunction', 'timeFrame': 'up to 4 months'}, {'measure': 'Correlation between retinal and peripheral endothelial dysfunction (assessment study visit)', 'timeFrame': 'up to 4 months'}, {'measure': 'Serum concentration of: CRP, ICAM-1, VCAM-1, VEGF, angiopoietin 2 and endostatin.', 'timeFrame': 'up to 4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 1 diabetes mellitus', 'Diabetic retinopathy', 'Pathogenesis', 'Dynamic Vessel Analyser', 'Endothelial dysfunction'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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\n\nHealthy subjects: Sex and age-matched control healthy subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For diabetic patients :\n\n * age between 20 and 60\n * type 1 diabetes mellitus\n * diabetes duration of more than 5 years\n * no diabetic retinopathy on fundus examination or fundus photographs\n * no systemic hypertension (defined as systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg)\n* For control subjects :\n\n * sex and age matching with the diabetic patients\n * no diabetes, no familial or personal history of elevated blood sugar\n * Non-diabetic subjects, criteria defined by a fasting glucose \\<1.10 g / l and an HbA1c \\<6.5% (according to Lariboisière biochemistry laboratory HbA1c)\n * no systemic hypertension (defined as systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg)\n * Subject with a normal ophthalmologic examination\n* For both diabetic patients and control subjects :\n\n * Subject that has signed informed consent\n * Subject affiliated to a social security\n * Subject available for a period of 4 months\n\nExclusion Criteria:\n\n* For both diabetic patients and control subjects :\n\n * presence of cataract or history of cataract surgery\n * intraocular pressure of more than 21 mmHg\n * treatment with vasoactive drugs\n * tobacco consumption of more than 20 cigarettes a day\n * Contraindications to trinitrin administration: hypersensitivity to trinitrin, treatment by sildenafil, heart disease, severe arterial hypotension, bradycardia, intracranial hypertension\n * Clinical Raynaud syndrome\n * Pregnant or breast-feeding subject\n * Subject whose age is \\<18 and\\> 60 years on the day of inclusion\n * Subject with cardiac disease, severe hypotension (BP \\<80/50 mmHg), a resting heart rate below 50 beats / minute\n * Subject intracranial hypertension\n * 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.\n * Subject has not signed an informed consent\n * Subject not affiliated to a social security\n * Subject not available for a period of 4 months'}, 'identificationModule': {'nctId': 'NCT01097551', 'acronym': 'DENDI', 'briefTitle': 'Endothelial Dysfunction and Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Assessment of Endothelial Dysfunction in Retinal and Peripheral Retinal Vessels in Diabetes', 'orgStudyIdInfo': {'id': 'P080608'}, 'secondaryIdInfos': [{'id': '2009-A0109552', 'type': 'OTHER', 'domain': 'Eudra CT'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with type 1 diabetes', 'description': 'Diabetes duration \\>= 5 years, age \\>= 18 and \\<= 60 years old, patients with no visible diabetic retinopathy, and no arterial hypertension', 'interventionNames': ['Drug: Trinitrin', 'Drug: Neosynephrine 10% collyrium', 'Drug: Iontophoresis with acetylcholine delivery', 'Device: Dynamic Vessel Analyzer']}, {'label': 'Healthy subjects', 'description': 'Sex and age-matched control healthy subjects', 'interventionNames': ['Drug: Trinitrin', 'Drug: Neosynephrine 10% collyrium', 'Drug: Iontophoresis with acetylcholine delivery', 'Device: Dynamic Vessel Analyzer']}], 'interventions': [{'name': 'Trinitrin', 'type': 'DRUG', 'description': 'Trinitrin: 2 sublingual pulverisations of 0.3 mg/dose', 'armGroupLabels': ['Healthy subjects', 'Patients with type 1 diabetes']}, {'name': 'Neosynephrine 10% collyrium', 'type': 'DRUG', 'description': 'Neosynephrine 10% collyrium: 2 drops', 'armGroupLabels': ['Healthy subjects', 'Patients with type 1 diabetes']}, {'name': 'Iontophoresis with acetylcholine delivery', 'type': 'DRUG', 'description': 'Iontophoresis with acetylcholine delivery', 'armGroupLabels': ['Healthy subjects', 'Patients with type 1 diabetes']}, {'name': 'Dynamic Vessel Analyzer', 'type': 'DEVICE', 'description': 'Dynamic Vessel Analyzer', 'armGroupLabels': ['Healthy subjects', 'Patients with type 1 diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': "Hôpital LARIBOISIERE Service d'Ophtalmologie", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Amélie LECLEIRE-COLLET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Pascale MASSIN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}