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A muscle protein may signal nerve damage in diabetes — study puts it to the test

NCT ID NCT07734597

Knowledge-focused Sponsor: GÜLDEN ANATACA 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This study investigates whether blood levels of irisin, a protein linked to glucose metabolism and nerve protection, differ in people with type 2 diabetes who have diabetic polyneuropathy (nerve damage) compared to those without it and healthy controls. Researchers will measure irisin in fasting blood samples from 81 participants. The goal is to see if irisin could serve as a biomarker to help identify or monitor this common diabetes complication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If irisin levels differ between groups, it could point toward a simple blood test to help detect or monitor diabetic nerve damage.
What could go wrong
This is a small observational study, not a treatment trial. Even if irisin correlates with neuropathy, it may not prove useful as a practical biomarker.

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.

Participants

About 81 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Sep 2026

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.

Who is studied

The study population will consist of adult participants aged between 30 and 75 years who are followed at the Internal Medicine outpatient clinic of Kanuni Sultan Süleyman Training and Research Hospital between jul, 2026 and semptember, 2026. A total of 81 participants will be enrolled and categorized into three groups according to clinical and electrophysiological evaluation findings: Group 1 (DPN+): Patients with Type 2 Diabetes Mellitus and confirmed diabetic polyneuropathy Group 2 (DPN-): Patients with Type 2 Diabetes Mellitus without evidence of diabetic polyneuropathy Group 3 (Healthy Controls): Individuals without diabetes mellitus or neuropathy Participants will be enrolled regardless of sex. Eligible participants must be capable of understanding and signing the informed consent form. Patients with neuropathy due to non-diabetic causes, chronic kidney disease, active infection, neuromuscular disorders, central nervous system diseases, or severe orthopedic conditions affectin

Ages

30 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age between 30 and 75 years * Diagnosis of Type 2 Diabetes Mellitus for at least 1 year (for diabetic groups) * Ability to understand and sign informed consent * Willingness to participate in the study Exclusion Criteria: * Neuropathy due to causes other than diabetes (e.g., vitamin B12 deficiency, chronic alcohol use, chemotherapy-induced neuropathy) * Chronic kidney disease (eGFR \<60 mL/min/1.73 m²) * Active infection * Myopathies or other muscle diseases * Central nervous system diseases (e.g., stroke, Parkinson disease) * Severe orthopedic conditions impairing mobility * Inability or unwillingness to provide informed consent

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy diabetic polyneuropathy polyneuropathy type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus type 2 Diabetic complications neurological Polyneuropathies

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Kanuni Sultan Süleyman Training and Research Hospital

    Istanbul, Turkey (Türkiye)

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