Role of Omega-3 Fatty Acids in Modulating Retinal Microvascular Changes in Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Retinal Artery Diameter
研究概览
简要总结
This double-blind, placebo-controlled randomized clinical trial evaluates the effects of omega-3 fatty acid supplementation on retinal vascular structure and function in children and adolescents with type 1 diabetes. The study compares omega-3 supplementation with placebo to assess changes in retinal microvascular parameters, retinal blood flow, visual function, and systemic biomarkers over time, as well as the safety and tolerability of supplementation during the study period.
详细描述
Type 1 diabetes mellitus is associated with early retinal microvascular and hemodynamics alterations that may precede clinically visible diabetic retinopathy. Omega-3 fatty acids have been reported to exert anti-inflammatory, vasoprotective, and neuroprotective effects, and may therefore help preserve retinal vascular integrity and ocular blood flow in individuals with diabetes. This randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the effects of omega-3 supplementation on retinal vascular structure and function in children with type 1 diabetes.
Participants were randomized to receive either omega-3 supplementation or placebo and were followed longitudinally over the study period. Serial ophthalmic and systemic assessments were performed to examine changes in retinal microvascular parameters, retinal blood flow, visual function, and selected systemic biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This was a double-blind, placebo-controlled randomized clinical trial. Participants, care providers, investigators, and outcome assessors were blinded to treatment allocation throughout the study period.
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes with earliest changes i.e. microaneurysms or changes in retinal vessels
排除标准
- •Presence of any ocular disease other than diabetic retinopathy Use of medications that may affect retinal vascular measurements or visual function outcomes Presence of systemic diseases other than diabetes (e.g., uncontrolled hypertension, autoimmune diseases) History of ocular surgery within the past 6 months Current participation in another interventional clinical trial
研究组 & 干预措施
Omega-3 Group
Participants in this arm received one oral capsule daily containing (1000 mg fish oil containing EPA 180 mg and DHA 120 mg) omega-3 fish oil supplementation for the duration of the study.
干预措施: Omega 3 Fish Oil supplements (Dietary Supplement)
Placebo Group
Participants in this arm received one oral placebo capsule daily, matched in appearance to the omega-3 supplement but containing no active omega-3 fatty acids, for the duration of the study.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Retinal Artery Diameter
时间窗: Baseline, 3 Months 6 Months 9 Months
Change in retinal artery measured using OCTA
Change in Retinal Vein Diameter
时间窗: Baseline, 3 Months 6 Months 9 Months
Change in retinal vein diameter measured using OCTA
Change in Foveal Avascular Zone (Area, Perimeter and Circulatory)
时间窗: Baseline, 3 Months, 6 Months, 9 Months
To measure the change in Foveal Avascular Zone parameter by using OCTA.
Central Retinal Artery (PSV, EDV, RI). Central retinal vein (Mean Velocity), Ophthalmic Artery (PSV, EDV, RI), Posterior Ciliary Artery (PSV, EDV, RI)
时间窗: Baseline, 3 Months, 6 Months, 9 Months
Central Retinal Artery (PSV, EDV, RI). Central retinal vein (Mean Velocity), Ophthalmic Artery (PSV, EDV, RI), Posterior Ciliary Artery (PSV, EDV, RI) blood flow is measured by doppler ultrasound
次要结局
- Visual Acuity(Baseline, 3 Months 6 Months 9 Months)
- Contrast Sensitivity(Baseline, 3 Months 6 Months 9 Months)
- Blood Sugar Random, Glycosylated hemoglobin (HbA1c), Lipid Profile (Total cholesterol, HDL, LDL, Triglycerides)(Baseline, 3 Months 6 Months 9 Months)
研究者
Nida Amin
Assistant Professor/HOD Optometry Department
University of Faisalabad