NCT05645068

Retinal Microvasculature by Optical Coherence Tomography Angiography During Integrating Physical Activity in Diabetic Subjects.

Pilot Study for the Evaluation of Retinal Microvasculature by OCT Angiography During a Multidisciplinary Management Program Integrating Physical Activity in Type 2 Diabetic Subjects.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Complications

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Optical Coherence Tomography Angiography	Optical Coherence Tomography Angiography
OTHER	multidisciplinary care program	multidisciplinary care program including sports activity

Timeline

• Start date: 2023-02-28
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-12-09
• Last updated: 2023-05-15

Locations

1 site across 1 country: France