Melatonin for people with diabetic peripheral neuropathy
Effect of Melatonin on the Clinical Outcomes in Type 2 Diabetic Patients With Peripheral Neuropathy
This trial will test whether adding melatonin to usual care helps adults with type 2 diabetes who have peripheral neuropathy by reducing oxidative stress, lowering inflammation, and improving symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07036796 on ClinicalTrials.gov |
What this trial studies
Adults aged 40–75 with type 2 diabetes and diagnosed diabetic peripheral neuropathy will receive melatonin as an adjunct to their usual care and undergo laboratory and clinical testing during the treatment period. The study will measure oxidative stress markers, inflammatory cytokines (for example TNF‑alpha, IL‑1, IL‑6), and clinical neuropathy outcomes to determine biological and symptomatic effects. Participants must have stable antidiabetic medication and will be excluded for conditions such as autoimmune disease, severe liver or kidney dysfunction, neurodegenerative disease, active infection, recent antioxidant or anti‑inflammatory use, pregnancy, or melatonin allergy. The phase 2 interventional trial is conducted at Ain Shams University Hospital in Cairo.
Who should consider this trial
Good fit: Ideal candidates are adults 40–75 years old with type 2 diabetes for at least one year who have a diagnosis of diabetic peripheral neuropathy and are on stable antidiabetic medication.
Not a fit: Patients with autoimmune disorders, significant liver or kidney dysfunction, neurodegenerative disease, active infection, recent antioxidant or anti‑inflammatory supplement use, pregnancy, or melatonin allergy are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, melatonin could lower nerve‑damaging oxidative stress and inflammation and produce modest improvements in neuropathic symptoms for people with type 2 diabetes.
How similar studies have performed: Preclinical studies and small clinical reports indicate melatonin has antioxidant and anti‑inflammatory effects, but well‑powered randomized trials in diabetic peripheral neuropathy are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 40-75 years diagnosed with type 2 DM. 2. Diabetes duration at least 1 year. 3. Patients diagnosed with diabetic peripheral neuropathy. 4. Stable antidiabetic medication for at least 1 month before enrollment and during the trial Exclusion Criteria: 1. Patients with autoimmune disorders (such as lupus and rheumatoid arthritis), thyroid diseases, peripheral arterial disease and cancer patients. 2. Patients with severe kidney or liver dysfunction. 3. Patients diagnosed with neurodegenerative diseases. 4. Active infection. 5. Use of medications or supplements known to cause or treat peripheral neuropathy. 6. Alcohol consumption or substance abuse. 7. Patients consuming any antioxidant supplements or anti-inflammatory medicines during or 3 months before enrollment. 8. Pregnancy or lactation or expecting to get pregnant during the study. 9. Allergy to melatonin.
Where this trial is running
Cairo
- Ain Shams University hospital — Cairo, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.