- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07329556
Skin Autofluorescence Assessment of Advanced Glycation End Products in Rheumatic Diseases
Evaluation of Advanced Glycation End Products Accumulation in Rheumatic Diseases Using Non-Invasive Skin Autofluorescence Measurements
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Altuğ Güner, MD
- Phone Number: +905337414088
- Email: altugguner555@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin Autofluorescence-Derived Advanced Glycation End Product Level
Time Frame: 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).
|
Baseline (single study visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of AGE Levels Between Rheumatic Disease Subtypes
Time Frame: Baseline (single study visit)
|
Comparison of skin autofluorescence-derived advanced glycation end-product (AGE) levels among different rheumatic disease subgroups and healthy controls.
|
Baseline (single study visit)
|
|
Association Between AGE Levels and Inflammatory Markers
Time Frame: Baseline
|
Association between skin autofluorescence-derived AGE levels and systemic inflammatory markers, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR).
|
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- Axial Spondyloarthritis
- Bone Diseases
- Musculoskeletal Diseases
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Genetic Diseases, Inborn
- Autoimmune Diseases
- Immune System Diseases
- Infections
- Spinal Diseases
- Spondylarthropathies
- Ankylosis
- Skin Diseases, Papulosquamous
- Skin Diseases
- Spondylarthritis
- Spondylitis
- Psoriasis
- Hereditary Autoinflammatory Diseases
- Arthritis, Infectious
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Crystal Arthropathies
- Spondylitis, Ankylosing
- Arthritis, Rheumatoid
- Arthritis, Psoriatic
- Connective Tissue Diseases
- Familial Mediterranean Fever
- Arthritis, Reactive
Other Study ID Numbers
- 2026-Rheumatology-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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