Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-01-25 @ 2:12 AM
Study NCT ID:
NCT05645068
Status:
UNKNOWN
Last Update Posted:
2023-05-15
First Post:
2022-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinal Microvasculature by Optical Coherence Tomography Angiography During Integrating Physical Activity in Diabetic Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048909', 'term': 'Diabetes Complications'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2022-12-01', 'studyFirstSubmitQcDate': '2022-12-01', 'lastUpdatePostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'coefficient of variation of the superficial retinal capillary plexus', 'timeFrame': 'week 3', 'description': 'coefficient of variation of the superficial retinal capillary plexus between day 0 and week 3 determinate by OCT Angiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Optical Coherence Tomography Angiography', 'Diabetic Macular Edema'], 'conditions': ['Diabetes Complications']}, 'descriptionModule': {'briefSummary': 'Diabetic retinopathy is a common condition of diabetes and can lead to blindness, making it one of the most feared complications of diabetes.\n\nRecently, it has been proven that the parameters measured by Optical Coherence Tomography (OCT) Angiography: the vascular density of the macular retinal capillary plexi and the foveolar avascular zone, can be modified after a high-intensity sports training program in healthy subjects.\n\nthe team wants to study the evolution of the macular, in type 2 diabetic subjects, before and after a stay in a care structure dedicated to the multidisciplinary and integrative management (nutrition, physical activity, therapeutic education) of a duration of 3 weeks.', 'detailedDescription': 'The prevention of vascular and neurological complications in diabetic subjects represents a major public health issue. Diabetic retinopathy is a common condition of diabetes and can lead to blindness, making it one of the most feared complications of diabetes.\n\nDiabetes management is global and aims at a stable glycemic balance putting the patient out of the micro and macrovascular complications linked to this pathology. It involves modifying the lifestyle of patients with the practice of appropriate physical activity, balancing daily food intake, not necessarily by taking insulin-sensitizing or hypoglycemic drug treatment, but also by management of other risk factors related to complications: dyslipidemia, weight, smoking, arterial blood pressure balance.\n\nThe use of Optical Coherence Tomography Angiography allow the evaluation of the microvasculature of the macula.\n\nDiabetic macular edema is the leading cause of vision loss in type 2 diabetic subjects mainly due to dysfunction of the macular microvasculature.\n\nMacular analysis via Optical Coherence Tomography Angiography can quickly and non-invasively predict the risk of occurrence of Diabetic macular edema and therefore that of a decrease in acuity and visual impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient for whom a 3-week multidisciplinary and integrative program was offered in a diabetology unit\n* Patient having given his consent\n* Patient affiliated to a social security scheme or equivalent\n* Patient with type 2 diabetes\n\nExclusion Criteria:\n\n* History of exudative or tractional retinal detachment\n* Intraocular foreign body\n* History of endophthalmitis\n* History of inflammatory disease of the retina\n* History of chorioretinitis\n* Patient with age-related macular degeneration\n* Patients with type 1 diabetes or secondary diabetes\n* Uncontrolled hypertension does not define Systolic arterial pressure (SAP) \\> 180 mmHg or Diastolic arterial pressure (DAP) \\> 110 mmHg\n* Patient who has already received intravitreal injections of anti-angiogenic molecules.\n* Pregnant or breastfeeding patient at the time of the study\n* Persons under a legal protection regime for adults (safeguard of justice, guardianship, curatorship, institutionalized, or under mandate for future protection)'}, 'identificationModule': {'nctId': 'NCT05645068', 'acronym': 'OCTACTIPH', 'briefTitle': 'Retinal Microvasculature by Optical Coherence Tomography Angiography During Integrating Physical Activity in Diabetic Subjects.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Pilot Study for the Evaluation of Retinal Microvasculature by OCT Angiography During a Multidisciplinary Management Program Integrating Physical Activity in Type 2 Diabetic Subjects.', 'orgStudyIdInfo': {'id': 'RC31/21/0612'}, 'secondaryIdInfos': [{'id': '2022-A02003-40', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Optical Coherence Tomography Angiography', 'interventionNames': ['Diagnostic Test: Optical Coherence Tomography Angiography', 'Other: multidisciplinary care program']}], 'interventions': [{'name': 'Optical Coherence Tomography Angiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Optical Coherence Tomography Angiography', 'armGroupLabels': ['Optical Coherence Tomography Angiography']}, {'name': 'multidisciplinary care program', 'type': 'OTHER', 'description': 'multidisciplinary care program including sports activity', 'armGroupLabels': ['Optical Coherence Tomography Angiography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31400', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fanny VARENNE, PH', 'role': 'CONTACT'}, {'name': 'Raphaël ADAM', 'role': 'CONTACT'}, {'name': 'Fanny VARENNE, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Emilie LOBINET, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Juliette SPIESS, PH', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Fanny VARENNE, PH', 'role': 'CONTACT', 'email': 'varenne.f@chu-toulouse.fr', 'phone': '05 61 77 11 07', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Fanny VARENNE, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}