Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy
Effect of Melatonin on the Clinical Outcomes in Type 2 Diabetic Patients With Peripheral Neuropathy
Ain Shams University
60 participants
Jul 4, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Patients aged 40-75 years diagnosed with type 2 DM.
- Diabetes duration at least 1 year.
- Patients diagnosed with diabetic peripheral neuropathy.
- Stable antidiabetic medication for at least 1 month before enrollment and during the trial
Exclusion Criteria9
- Patients with autoimmune disorders (such as lupus and rheumatoid arthritis), thyroid diseases, peripheral arterial disease and cancer patients.
- Patients with severe kidney or liver dysfunction.
- Patients diagnosed with neurodegenerative diseases.
- Active infection.
- Use of medications or supplements known to cause or treat peripheral neuropathy.
- Alcohol consumption or substance abuse.
- Patients consuming any antioxidant supplements or anti-inflammatory medicines during or 3 months before enrollment.
- Pregnancy or lactation or expecting to get pregnant during the study.
- Allergy to melatonin.
Interventions
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)
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NCT07036796