Combined Antioxidant Therapy on Oxidative Stress, Mitochondrial Dysfunction Markers in Diabetic Retinopathy

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The present study aims to support previous research on antioxidant therapy effects in diabetic retinopathy outcome. The investigators intend to assess 180 patients with diabetic retinopathy in different stages (moderate, severe and proliferative), whom either will be assigned to placebo group or combined antioxidant therapy. Each group will receive the intervention for 12 months. Such intervention consists in taking one tablet (placebo or antioxidant therapy) orally, a day.

At baseline, blood and urine samples will be collected in order to assess metabolic and oxidative stress status, mitochondrial function or dysfunction, liver and kidney function. In addition, fluorescein angiography will be done for the categorization of diabetic retinopathy. After six months and at the end of the intervention, blood and urine measurements as well as angiographies will be done for comparing the outcomes between both groups and correlate oxidative stress status, mitochondrial dysfunction with grade of retinopathy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Guadalajara
• Collaborator: Instituto Mexicano del Seguro Social
• Treatments: Antioxidants

Criteria

Inclusion Criteria:

• Patients with type 2 diabetes with moderate or severe non-proliferative diabetic retinopathy without clinically significant macular edema.

• Patients with type 2 diabetes with proliferative diabetic retinopathy without clinically significant macular edema.

• In current treatment that may include: metformin, glibenclamide, pravastatin, bezafibrate, losartan, nifedipine or captopril.

• HbA1c equal or lower than 9%

• LDL under 190mg/dl, triglycerides under 500mg/dl)

• Blood pressure under 180/110 mmHg

• Non-smoker or inactive for at least 6 months

• Signed informed consent

Exclusion Criteria:

• Antioxidant therapy intake over the last 6 months. Antioxidant dietary intake that surpasses the daily DIR (dietary intake recommendations)

• Patients who require secondary intervention (laser surgery)

• Patients with previous history of myocardial infarction, ictus or severe peripheral vasculopathy

• Patients with pathologies that increase oxidative stress

• Patients with neurodegenerative or carcinogen processes

• Hepatic or renal failure

• Pregnancy

• Patients with hypersensitivity to therapy components

• Other ocular pathologies, such as cataract, glaucoma, corneal dystrophy, macular degeneration among others

• Patients who are currently participating in other clinical trials