Evaluation of Serum Irisin Levels as a Potential Biomarker in Patients With Diabetic Polyneuropathy: A Single-center Prospective Cross-sectional Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Serum Irisin Concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Serum Irisin Concentration
时间窗: 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..
次要结局
- Glycated Hemoglobin (HbA1c) Concentration(Baseline)
- Fasting Plasma Glucose(Baseline)
- Body Mass Index (BMI)(Baseline)
- Presence of Diabetic Polyneuropathy Confirmed by Electrophysiological Examination(Baseline)
研究者
GÜLDEN ANATACA
Assistant Professor
Istanbul Saglik Bilimleri University