Melatonin Treatment Effects on Type 2 Diabetes Patients with Diabetic Peripheral Neuropathy

What this Trial Is About

This research aims to evaluate the effect of melatonin as an additional therapy on oxidative stress, inflammatory markers, and clinical outcomes in patients with type 2 diabetes who have diabetic peripheral neuropathy DPN. DPN is a common complication affecting up to half of diabetic patients during their lifetime, causing symptoms such as tingling, burning, and pain. The study investigates how melatonin might influence disease progression by targeting underlying oxidative and inflammatory pathways involved in nerve damage. Participants will be randomly assigned to one of two groups one group will receive 10 mg of melatonin daily before bedtime for 12 weeks alongside their standard diabetes treatment, while the other group will continue with standard therapy alone for the same duration. Melatonin is studied for its antioxidant and anti-inflammatory properties through activation of specific cellular pathways. The trial will measure changes in key markers like nuclear factor erythroid 2-related factor Nrf2 and tumor necrosis factor-alpha TNF-alpha. Throughout the study, participants will undergo assessments at the start and end of the 12-week period, including laboratory tests for oxidative and inflammatory markers and clinical evaluations using questionnaires such as the Toronto Clinical Scoring System and the Michigan Neuropathy Screening Instrument. Blood samples will be collected and stored for detailed analysis. The studys main outcome is the change in Nrf2 levels, with additional outcomes measuring inflammatory markers and neuropathy symptoms to understand melatonins potential impact on patient health and quality of life.

Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy