Pilot Study for the Evaluation of Retinal Microvasculature by OCT Angiography During a Multidisciplinary Management Program Integrating Physical Activity in Type 2 Diabetic Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- coefficient of variation of the superficial retinal capillary plexus
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
coefficient of variation of the superficial retinal capillary plexus
时间窗: week 3
coefficient of variation of the superficial retinal capillary plexus between day 0 and week 3 determinate by OCT Angiography
次要结局
未报告次要终点