Is Serum Irisin Level a Biomarker in Diabetic Polyneuropathy?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Polyneuropathies, Diabetic Complications Neurological, Diabetes Mellitus Type 2. Basic parameters: 30 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Serum Irisin Levels as a Potential Biomarker in Patients With Diabetic Polyneuropathy: A Single-center Prospective Cross-sectional Observational Study
Overview
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.
Detailed description
Diabetes Mellitus is characterized by insulin resistance and/or relative insulin deficiency and is associated with several microvascular complications. Diabetic peripheral polyneuropathy is among the most common and disabling complications, leading to sensory loss, proprioceptive impairment, postural instability, gait abnormalities, and increased fall risk.
Irisin, a myokine released from skeletal muscle during physical activity, has emerged as an important regulator of systemic metabolism. Reduced irisin levels have been associated with insulin resistance, chronic inflammation, mitochondrial dysfunction, and skeletal muscle atrophy, all of which may contribute to the progression of diabetic neuropathy.
Although previous studies have separately investigated diabetic neuropathy and serum irisin levels, limited data exist regarding their direct relationship. Therefore, this study was designed to evaluate serum irisin levels in patients with diabetic polyneuropathy from a holistic perspective and to investigate its potential role as a biomarker.
Primary outcome measures
- Serum Irisin Concentration [Time frame: Baseline]
Secondary outcome measures (4)
- Glycated Hemoglobin (HbA1c) Concentration [Time frame: Baseline]
- Fasting Plasma Glucose [Time frame: Baseline]
- Body Mass Index (BMI) [Time frame: Baseline]
- Presence of Diabetic Polyneuropathy Confirmed by Electrophysiological Examination [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Turkey (Türkiye) · 1 center
- Kanuni Sultan Süleyman Training and Research Hospital — Istanbul
Publications
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07734597 · KAEK/2026.05.190