Is Serum Irisin Level a Biomarker in Diabetic Polyneuropathy?

ConditionsPolyneuropathies Diabetic Complications Neurological Diabetes Mellitus Type 2

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age30-75

SponsorGÜLDEN ANATACA

About this trial

Diabetic polyneuropathy is a common complication of type 2 diabetes mellitus associated with sensory impairment and functional disability. Irisin is a myokine that has been implicated in glucose metabolism and neuroprotection. This prospective observational case-control study aims to evaluate serum irisin concentrations in patients with diabetic polyneuropathy compared with diabetic patients without neuropathy and healthy controls, and to investigate whether serum irisin may serve as a biomarker for diabetic polyneuropathy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

81 Participants

are grouped into 3 trial groups

Group A: Group 1: DPN+

Group B: Group 2: DPN-

Group C: Group 3: Healthy Control

Trial outcomes

Primary outcomes

Serum Irisin Concentration

Serum irisin concentration (ng/mL) will be measured from fasting venous blood samples using a commercially available enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer's instructions. Serum irisin concentrations will be compared among participants with diabetic polyneuropathy (DPN+), participants with Type 2 Diabetes Mellitus without diabetic polyneuropathy (DPN-), and healthy control participants. The primary objective is to evaluate whether serum irisin concentration may serve as a biomarker for diabetic polyneuropathy..

Time frame

Baseline

Secondary outcomes

Glycated Hemoglobin (HbA1c) Concentration

Glycated hemoglobin (HbA1c) concentration (%) will be measured using standardized high-performance liquid chromatography (HPLC) methods in the hospital biochemistry laboratory. HbA1c levels will be compared among study groups and analyzed for their relationship with serum irisin concentration.

Time frame

Baseline

Fasting Plasma Glucose

Fasting plasma glucose concentration (mg/dL) will be measured after an overnight fast using routine biochemical laboratory methods. Fasting glucose levels will be compared among study groups and evaluated for their association with serum irisin concentration.

Time frame

Baseline

Body Mass Index (BMI)

Body mass index (kg/m²) will be calculated by dividing body weight in kilograms by the square of height in meters (kg/m²). BMI values will be compared among the three study groups and analyzed for their association with serum irisin concentration.

Time frame

Baseline

Presence of Diabetic Polyneuropathy Confirmed by Electrophysiological Examination

Diabetic polyneuropathy will be diagnosed using standardized neurological examination and nerve conduction studies (electromyography, EMG) according to predefined diagnostic criteria described in the study protocol. This outcome is not based on a numerical rating scale. Participants will be classified into one of the following categories: * Diabetic polyneuropathy present (DPN+) * Diabetic polyneuropathy absent (DPN-) The presence or absence of diabetic polyneuropathy will be used for comparison with serum irisin concentration and other metabolic variables.

Time frame

Baseline

Other outcomes

Correlation Between Serum Irisin Concentration and Clinical Parameters

Correlation analyses will be performed to evaluate the relationship between serum irisin concentration and metabolic and clinical parameters, including: * Glycated hemoglobin (HbA1c) * Fasting plasma glucose * Body mass index (BMI) * Total cholesterol * LDL cholesterol * HDL cholesterol * Triglycerides * Duration of diabetes Presence of diabetic polyneuropathy confirmed by electrophysiological examination Correlation coefficients will be calculated using Pearson or Spearman correlation analysis depending on data distribution.

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GÜLDEN ANATACA

Lead sponsor

Istanbul Saglik Bilimleri University

Sponsor institution

Source ClinicalTrials.gov

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