Could a sleep hormone ease diabetic nerve damage?
NCT ID NCT07036796
First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time
Summary
This study investigates whether adding melatonin to standard diabetes care can improve symptoms of diabetic peripheral neuropathy, a common complication causing pain and numbness in the feet and hands. The trial includes 60 adults aged 40-75 with type 2 diabetes and diagnosed nerve damage. Researchers will measure changes in markers of oxidative stress and inflammation, as well as symptom scores, over the treatment period.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- melatonin, a hormone supplement with antioxidant and anti-inflammatory properties
- What this could lead to
- If it works, this could point toward a simple, low-cost supplement to help manage diabetic nerve damage and reduce pain or numbness.
- What could go wrong
- This is a small, early-phase trial with only 60 participants, so results may not apply widely. Melatonin can cause drowsiness and may interact with other medications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ain Shams University hospital
RECRUITINGCairo, Egypt
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