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Can a sleep hormone protect diabetic kidneys?

NCT ID NCT07825961

Disease control Sponsor: Tanta University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers at Tanta University are comparing melatonin with folic acid in adults who have type 2 diabetes and early kidney damage. All 75 participants receive standard diabetes care, with one group adding melatonin (3 mg daily) and another adding folic acid (400 µg daily). The study tracks changes in urine protein levels and kidney filtration rate to see whether either supplement slows kidney damage.

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 the body makes to regulate sleep, given as a daily supplement alongside standard diabetes care
What this could lead to
If melatonin helps, it could offer a low-cost daily pill to slow kidney damage in people with diabetes, on top of their usual treatment.
What could go wrong
This is a small, single-center study of 75 people, so any benefit may be modest or may not hold up in larger trials. Melatonin can cause drowsiness and may interact with other medicines.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

75 people

The number who actually took part.

Started

Apr 2025

Finished

Jul 2026

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

18 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: * Adults aged 18-75 years. * Patients with a confirmed diagnosis of Type 2 diabetes and diabetic nephropathy, as indicated by an elevated urine albumin-to-creatinine ratio (UACR ≥ 30 mg/g) or a decreased estimated glomerular filtration rate (eGFR \< 60 mL/min/1.73 m²). Exclusion Criteria: * Patients who are expectant or breastfeeding. * Have significant comorbidities. * Have rapidly declining renal function. * Have acute kidney injury.

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Conditions

The condition(s) this trial relates to.

diabetic kidney disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic nephropathy Folic acid Melatonin

Contacts and locations

Locations

  • Tanta University

    Tanta, El-Gharbia, 31527, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.