Diabetes Mellitus Type 2, Diabetic Complications Neurological, Polyneuropathies
Conditions
Keywords
Biomarker, Type 2 Diabetes Mellitus, Diabetic polyneuropathies, Serum Irisin
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.
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.
Interventions
None listed
Sponsors
GÜLDEN ANATACA
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Irisin Concentration | Baseline | 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.. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycated Hemoglobin (HbA1c) Concentration | Baseline | 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. |
| Fasting Plasma Glucose | Baseline | 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. |
| Body Mass Index (BMI) | Baseline | 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. |
| Presence of Diabetic Polyneuropathy Confirmed by Electrophysiological Examination | Baseline | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTgülden ANATACA
Outcome results
None listed