Could a sleep hormone ease diabetic nerve damage?

NCT ID NCT07036796

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

40 to 75 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Ain Shams University hospital

    RECRUITING

    Cairo, Egypt

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