RecruitingPhase 2NCT07036796

Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy

Effect of Melatonin on the Clinical Outcomes in Type 2 Diabetic Patients With Peripheral Neuropathy

Sponsor

Ain Shams University

Enrollment

60 participants

Start Date

Jul 4, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetic Peripheral Neuropathy Diabetic Neuropathy Diabetic Peripheral Neuropathy in Type 2 Diabetic Patients

Summary

The aim of the current study is to measure the effect of melatonin as adjunct therapy on oxidative stress, inflammatory markers and clinical outcome in type 2 diabetic patients with diabetic peripheral neuropathy.

Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether melatonin supplements can reduce nerve pain in the feet and legs (diabetic peripheral neuropathy) in people with type 2 diabetes. **You may be eligible if...** - You are between 40 and 75 years old - You have type 2 diabetes diagnosed for at least 1 year - You have been diagnosed with diabetic peripheral neuropathy (numbness, tingling, or pain in the feet/legs due to diabetes) - Your diabetes medications have been stable for at least 1 month **You may NOT be eligible if...** - You have type 1 diabetes - You have severe kidney or liver disease - You are pregnant or planning to become pregnant - You are already taking melatonin supplements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMelatonin

Melatonin (N-acetyl-5-methoxytryptamine), also called the hormone of darkness, secreted primarily by the pineal gland. Possesses antioxidant, anti-inflammatory, anti-diabetic and neuroprotective effects. All of which could be explained by its activation of Nrf2 signaling pathway. Melatonin administration has shown to improve motor nerve conduction velocity and nerve blood flow, reduce the levels of pro-inflammatory cytokines, reinforce antioxidant defense, and decrease DNA fragmentation through upregulating nrf2 pathway, when tested in mice with diabetic peripheral neuropathy. Moreover, early treatment with melatonin has shown to prevent developing diabetic neuropathy in streptozotocin induced diabetic mice.

Locations(1)

Ain Shams University hospital

Cairo, Egypt

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NCT07036796

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