Retinal Microvasculature by Optical Coherence Tomography Angiography During Integrating Physical Activity in Diabetic Subjects.
NCT ID: NCT05645068
Last Updated: 2023-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2023-02-28
2024-03-31
Brief Summary
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Recently, 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.
the 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.
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Detailed Description
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Diabetes 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.
The use of Optical Coherence Tomography Angiography allow the evaluation of the microvasculature of the macula.
Diabetic macular edema is the leading cause of vision loss in type 2 diabetic subjects mainly due to dysfunction of the macular microvasculature.
Macular 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Optical Coherence Tomography Angiography
Optical Coherence Tomography Angiography
Optical Coherence Tomography Angiography
multidisciplinary care program
multidisciplinary care program including sports activity
Interventions
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Optical Coherence Tomography Angiography
Optical Coherence Tomography Angiography
multidisciplinary care program
multidisciplinary care program including sports activity
Eligibility Criteria
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Inclusion Criteria
* Patient having given his consent
* Patient affiliated to a social security scheme or equivalent
* Patient with type 2 diabetes
Exclusion Criteria
* Intraocular foreign body
* History of endophthalmitis
* History of inflammatory disease of the retina
* History of chorioretinitis
* Patient with age-related macular degeneration
* Patients with type 1 diabetes or secondary diabetes
* Uncontrolled hypertension does not define Systolic arterial pressure (SAP) \> 180 mmHg or Diastolic arterial pressure (DAP) \> 110 mmHg
* Patient who has already received intravitreal injections of anti-angiogenic molecules.
* Pregnant or breastfeeding patient at the time of the study
* Persons under a legal protection regime for adults (safeguard of justice, guardianship, curatorship, institutionalized, or under mandate for future protection)
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Fanny VARENNE, PH
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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CHU de Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Fanny VARENNE, PH
Role: primary
Raphaël ADAM
Role: backup
Other Identifiers
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2022-A02003-40
Identifier Type: OTHER
Identifier Source: secondary_id
RC31/21/0612
Identifier Type: -
Identifier Source: org_study_id
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