Clinical trial NCT05645068: Retinal Microvasculature by Optical Coherence Tomography Angiography During Integrating Physical Activity in Diabetic Subjects.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Complications
Keywords: Optical Coherence Tomography Angiography
Diabetic Macular Edema
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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 (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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patient for whom a 3-week multidisciplinary and integrative program was offered in a diabetology unit
* Patient having given his consent
* Patient affiliated to a social security scheme or equivalent
* Patient with type 2 diabetes

Exclusion Criteria:

* 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 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)

Primary outcomes:
measure: coefficient of variation of the superficial retinal capillary plexus
timeFrame: week 3
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Fanny VARENNE, PH
role: PRINCIPAL_INVESTIGATOR
References: