Blood Based Vascular Marker Responses to Ocufolin® in Diabetic Retinopathy Patients Carrying MTHFR Polymorphisms.

Abstract

Background: Patients with inborn errors of metabolism related to Methylenetetrahydrofolate reductase (MTHFR) gene variants are at an increased risk for microvascular complications resulting from diabetic retinopathy. Early intervention with targeted nutritional support, particularly folate supplementation, may help stabilize metabolic function and slow the progression of diseases such as diabetes and hypertension, especially before irreversible structural damage occurs.

Objectives: To assess the effects of the folate supplement Ocufolin^® on serum markers in patients with Type 2 diabetes (T2D) and mild diabetic retinopathy (MDR).

Design: Prospective Cohort Study.

Methods: Ten patients with both MDR and MTHFR polymorphisms (C677T or A1298C) were enrolled in the present study and received Ocufolin^® to address errors in folate methylation metabolism. Patients were excluded if they had a history of other ocular or systemic diseases. Serum biomarkers associated with clinical chemistry (homocysteine, high-sensitivity C-reactive protein [hs-CRP], myeloperoxidase [MPO], fasting insulin, triglycerides, total cholesterol, high density lipoprotein [HDL], low density lipoprotein [LDL], Oxidized-LDL [Ox-LDL], vascular endothelial growth factor [VEGF], D-Dimer, hemoglobin A1c [HbA1c] and glutathione) were measured pre-and post-intervention.

Result: Treatment with Ocufolin^® resulted in a 23% decrease in serum homocysteine (P = .005), an 18% decrease in hsCRP, a 13% decrease in fasting insulin, a 15% increase in D-Dimer (P = .03) and a 47% decrease in VEGF (P = .04). Additionally, there was a 9% increase in glutathione, a 2% increase in MPO, a 6% reduction in triglycerides, a 3% increase in total cholesterol, a 4% increase in HDL, a 4% increase in LDL, an 8% increase in Ox-LDL. HbA1c did not change.

Conclusion: Normalizing folate metabolism through Ocufolin^® significantly improved key blood-based biomarkers in patients with diabetic retinopathy. These metabolic improvements may underlie enhanced retinal perfusion and reduced oxidative stress, suggesting potential adjunctive therapeutic benefits for managing vascular retinopathies in this population.