Is Serum Irisin Level a Biomarker in Diabetic Polyneuropathy?

NCT07734597 | Not Yet Recruiting

• 1 other identifier: KAEK/2026.05.190
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polyneuropathies; Diabetic Complications Neurological; Diabetes Mellitus Type 2

Keywords

Biomarker; Type 2 Diabetes Mellitus; Diabetic polyneuropathies; Serum Irisin

Outcome Measures

Primary Outcomes (1)

• 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..

  Baseline

Secondary Outcomes (4)

• Glycated Hemoglobin (HbA1c) Concentration

  Baseline

• Fasting Plasma Glucose

  Baseline

• Body Mass Index (BMI)

  Baseline

• Presence of Diabetic Polyneuropathy Confirmed by Electrophysiological Examination

  Baseline

Other Outcomes (1)

• Correlation Between Serum Irisin Concentration and Clinical Parameters

  Baseline

Study Arms (3)

Group 1: DPN+

Patients diagnosed with Type 2 Diabetes Mellitus and diabetic polyneuropathy confirmed by clinical and electrophysiological evaluation.

Group 2: DPN-

Patients diagnosed with Type 2 Diabetes Mellitus without evidence of diabetic polyneuropathy.

Group 3: Healthy Control

Participants without diabetes mellitus or neuropathy.

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GÜLDEN ANATACA: lead

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• Callaghan BC, Cheng HT, Stables CL, Smith AL, Feldman EL. Diabetic neuropathy: clinical manifestations and current treatments. Lancet Neurol. 2012 Jun;11(6):521-34. doi: 10.1016/S1474-4422(12)70065-0. Epub 2012 May 16.

  PMID: 22608666 BACKGROUND

• Colaianni G, Cuscito C, Mongelli T, Oranger A, Mori G, Brunetti G, Colucci S, Cinti S, Grano M. Irisin enhances osteoblast differentiation in vitro. Int J Endocrinol. 2014;2014:902186. doi: 10.1155/2014/902186. Epub 2014 Mar 4.

  PMID: 24723951 BACKGROUND

• Hicks CW, Selvin E. Epidemiology of Peripheral Neuropathy and Lower Extremity Disease in Diabetes. Curr Diab Rep. 2019 Aug 27;19(10):86. doi: 10.1007/s11892-019-1212-8.

  PMID: 31456118 BACKGROUND

• Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.

  PMID: 20876709 RESULT

MeSH Terms

Conditions

Polyneuropathies; Diabetes Mellitus, Type 2; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetes Complications

Central Study Contacts

gülden ANATACA

CONTACT

+905059284244; ganataca@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 29, 2026
• Study Start: July 30, 2026
• Primary Completion: July 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

TU (1)