Retinal Microvasculature by OCT Angiography During Integrating Physical Activity in Type 2 Diabetic Subjects. (OCTACTIPH)
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|ClinicalTrials.gov Identifier: NCT05645068|
Recruitment Status : Not yet recruiting
First Posted : December 9, 2022
Last Update Posted : December 9, 2022
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Diabetic retinopathy is a common condition of diabetes and can lead to blindness, making it one of the most feared complications of diabetes.
Recently, it has been proven that the parameters measured by Optical Coherence Tomography 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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Complications||Diagnostic Test: Optical Coherence Tomography Angiography Other: multidisciplinary care program||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study for the Evaluation of Retinal Microvasculature by OCT Angiography During a Multidisciplinary Management Program Integrating Physical Activity in Type 2 Diabetic Subjects.|
|Estimated Study Start Date :||December 2022|
|Estimated Primary Completion Date :||March 2024|
|Estimated Study Completion Date :||March 2024|
|Experimental: Optical Coherence Tomography Angiography||
Diagnostic Test: Optical Coherence Tomography Angiography
Optical Coherence Tomography Angiography
Other: multidisciplinary care program
multidisciplinary care program including sports activity
- coefficient of variation of the superficial retinal capillary plexus [ Time Frame: week 3 ]coefficient of variation of the superficial retinal capillary plexus between day 0 and week 3
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patient for whom a 3-week multidisciplinary and integrative program was offered in the Diabetology unit of the SSR la Fontaine Salée in Salies du Salat
- Patient having given his consent
- Patient affiliated to a social security scheme or equivalent
- Patient with type 2 diabetes
- History of exudative or tractional retinal detachment
- 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 PAS > 180 mmHg or PAD > 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05645068
|Contact: Fanny VARENNE, PH||05 61 77 11 07 ext +firstname.lastname@example.org|
|CHU de Toulouse|
|Toulouse, France, 31400|
|Contact: Fanny VARENNE, PH|
|Contact: Raphaël ADAM|
|Principal Investigator: Fanny VARENNE, PH|
|Principal Investigator: Emilie LOBINET, PH|
|Sub-Investigator: Juliette SPIESS, PH|
|Principal Investigator:||Fanny VARENNE, PH||Toulouse University Hospital|
|Responsible Party:||University Hospital, Toulouse|
|Other Study ID Numbers:||
2022-A02003-40 ( Other Identifier: ID-RCB )
|First Posted:||December 9, 2022 Key Record Dates|
|Last Update Posted:||December 9, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Optical Coherence Tomography Angiography
Diabetic Macular Edema
Endocrine System Diseases