Evaluation of Advanced Glycation End Products Accumulation in Rheumatic Diseases Using Non-Invasive Skin Autofluorescence Measurements
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Skin Autofluorescence-Derived Advanced Glycation End Product Level
研究概览
简要总结
Rheumatic diseases are chronic inflammatory conditions that can lead to long-term tissue damage and increased cardiovascular and metabolic risk. Advanced glycation end products (AGEs) are harmful molecules that accumulate in the body over time and are known to promote inflammation and oxidative stress. Increased AGE burden has been implicated in several chronic diseases; however, its role in rheumatic diseases has not been fully clarified.
This observational, cross-sectional study aims to evaluate the accumulation of AGEs in patients with various rheumatic diseases compared with healthy individuals. AGE levels will be assessed non-invasively using skin autofluorescence measurements.
By comparing AGE burden between patients and healthy controls, this study seeks to improve understanding of the potential role of AGEs in the pathophysiology of rheumatic diseases and to explore their usefulness as a non-invasive biomarker in clinical practice.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 75 years
- •Diagnosis of an inflammatory rheumatic disease (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, connective tissue diseases, Behçet disease, familial Mediterranean fever, or crystal arthropathies), confirmed by a rheumatologist
- •Healthy volunteers without a history of rheumatic or chronic inflammatory disease (for the control group)
- •Ability to undergo non-invasive skin autofluorescence measurement
- •Ability and willingness to provide written informed consent
排除标准
- •Diagnosis of diabetes mellitus (type 1 or type 2)
- •Chronic kidney disease with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m²
- •Active malignancy or history of malignancy within the past 5 years
- •Presence of acute infection or acute inflammatory condition at the time of assessment
- •Secondary causes of systemic inflammation unrelated to the underlying rheumatic disease (e.g., uncontrolled endocrine disorders, chronic liver disease)
- •Use of medications known to markedly affect AGE accumulation or skin autofluorescence measurements (e.g., recent high-dose systemic glucocorticoids)
- •Pregnancy or breastfeeding
- •Presence of significant skin conditions (e.g., extensive dermatitis, scars, tattoos, or burns) at the measurement site that may interfere with skin autofluorescence assessment
- •Inability to comply with study procedures or to provide informed consent
研究组 & 干预措施
Rheumatic Diseases Group
Patients diagnosed with inflammatory rheumatic diseases undergoing skin autofluorescence measurement.
Healthy Control Group
Age- and sex-matched healthy volunteers without a diagnosis of rheumatic disease.
结局指标
主要结局
Skin Autofluorescence-Derived Advanced Glycation End Product Level
时间窗: Baseline (single study visit)
Advanced glycation end-product (AGE) accumulation assessed non-invasively by skin autofluorescence measurement using a validated AGE Reader device, expressed in arbitrary units (AU).
次要结局
- Comparison of AGE Levels Between Rheumatic Disease Subtypes(Baseline (single study visit))
- Association Between AGE Levels and Inflammatory Markers(Baseline)
研究者
Taner Dandinoğlu
Principal Investigator
Bursa City Hospital