ClinicalTrials.gov record 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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational case-control study compares skin autofluorescence, a non-invasive measure of advanced glycation end products (AGEs), between adults with various inflammatory rheumatic diseases and healthy volunteers. Each participant has a single baseline skin autofluorescence measurement; inflammatory markers are also considered. The study seeks to learn whether AGE burden differs between patient groups and controls and how it relates to inflammation and disease subtype.
What it is studying. Whether the amount of AGEs measured by non-invasive skin autofluorescence differs between people with inflammatory rheumatic diseases and healthy volunteers, and how those AGE levels relate to inflammatory blood markers and to different rheumatic disease subtypes.
What the researchers hope to learn. To improve understanding of AGE accumulation in different rheumatic diseases; to compare AGE levels across disease subtypes and with healthy controls; and to explore whether skin autofluorescence could be a useful non-invasive biomarker linked to inflammation.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Take part in a single study visit that includes a non‑invasive skin autofluorescence measurement to assess advanced glycation end‑product (AGE) accumulation. Participants will have relevant clinical information recorded and systemic inflammatory markers (for example C‑reactive protein and erythrocyte sedimentation rate) assessed or recorded for comparison. You will be asked to give written informed consent and confirm you can undergo the skin measurement. There are no invasive procedures listed; the visit may include a review of medical history and current medications.
How the study is structured. Observational, prospective case-control study. Adults with diagnosed inflammatory rheumatic diseases form one group and age/sex-matched healthy volunteers form a control group. Participants attend a single study visit for a non-invasive skin autofluorescence measurement (using a validated AGE Reader device) and collection of routine inflammatory markers for comparison.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on familial Mediterranean fever
Important dates
- Study start
- Jan 15, 2026 (estimated)
- Primary completion
- Jan 15, 2027 (estimated)
- Study completion
- Apr 15, 2027 (estimated)
- Target enrollment
- 300 participants (estimated)
- Last updated on registry
- Jan 9, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Bursa City Hospital
- Principal investigator
- Taner Dandinoğlu, Principal Investigator
Bursa City Hospital
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Altuğ Güner, MD 📞 +905337414088 ✉ altugguner555@gmail.com
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.
Terms used on this page · explanations by MedicalUpdates.ai
- biomarker
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
- control group
- The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- estimated glomerular filtration rate
- A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
- glucocorticoids
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials