Efficacy of Ubiquinone and Combined Antioxidant Therapy on Progression, Oxidative Stress Markers and Mitochondrial Dysfunction in Non-proliferative Diabetic Retinopathy: A Phase 2a Randomized Double-blind Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Oxidative Stress markers
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of ubiquinone and combined antioxidant therapy on progression, clinical regression, oxidative stress markers and mitochondrial dysfunction in non-proliferative diabetic retinopathy.
详细描述
The investigators are interested in demonstrating the efficacy of Ubiquinone and combined antioxidant therapy in the pharmacological management of diabetic retinopathy since early stages.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with type 2 diabetes mellitus
- •Patients with non proliferative diabetic retinopathy
- •Glycated hemoglobin < 12.0%
- •Signing of informed consent
排除标准
- •Patients with clinically significant macular edema
- •Patients with diabetic retinopathy advanced lesions that have required or require specific treatment (laser, vitrectomy)
- •Pretreatment with argon laser or excimer laser Ophthalmology surgery
- •Any other associated ocular pathology (glaucoma, cataracts, changing cornea dystrophy, macular degeneration)
- •Pregnancy, lactation, inadequate use of contraception
- •Antioxidant drug and/or supplements six months previous to enrollment
- •Renal and/or hepatic failure
- •Age under 30 or over 75 years
- •Severe cardiovascular disease (myocardial infarction, stroke, severe peripheral vasculopathy)
- •Blood dyscrasias
- •Have or have had cancer or other serious illness
- •Neurodegenerative process
- •Allergy to vitamins
研究组 & 干预措施
Ubiquinone
400mg daily of oral ubiquinone for 24 weeks
干预措施: Ubiquinone (Drug)
Combined antioxidant therapy
(1mg copper + 20mg zinc + 180mg vitamin C + 30mg vitamin E + 1mg zeaxanthin + 4mg astaxanthin + 10mg lutein) daily of oral antioxidant combined therapy for 24 weeks
干预措施: Combined antioxidant therapy (Drug)
Placebo
Placebo. 100mg daily oral intake for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Oxidative Stress markers
时间窗: 24 weeks
In this study the oxidative stress markers are composed of lipid peroxidation, nitric oxide, erythrocyte glutathion peroxidase activity, erythrocyte catalase activity, total antioxidant capacity and erythrocyte membrane fluidity. * Lipid peroxidation (baseline and final values) given as malondialdehyde (MDA) and 4-hydroxyalkenals (4HDA) expressed in μmol/L * Nitric oxide (NO) Levels of the NO catabolites nitrites/nitrates expressed in pmol/mL (baseline and final values) * Erythrocyte glutathion peroxidase activity measured in U/min/mg protein (baseline and final values) * Erythrocyte catalase activity expressed in U/mg protein (baseline and final values) * Total antioxidant capacity measured in milliequivalent/mL (baseline and final values) * Erythrocyte membrane fluidity, calculated using the fluorescence ratio of the excimer (Ie) to monomer (Im). The Ie/Im ratio.
次要结局
- Mitochondrial dysfunction markers(24 weeks)
- Progression and regression of non-proliferative diabetic retinopathy(24 weeks)
研究者
Alejandra Guillermina Miranda Diaz
PhD
University of Guadalajara