Rheumatoid Arthritis (RANCT07329556
Skin Autofluorescence Assessment of Advanced Glycation End Products in Rheumatic Diseases
An observational study of Rheumatoid Arthritis (RA and Ankylosing Spondylitis, run by Bursa City Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis (RA, Ankylosing Spondylitis, Psoriatic Arthritis
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to 15 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 to 75 years diagnosed with inflammatory rheumatic diseases who are followed at a tertiary rheumatology outpatient clinic, as well as age- and sex-matched healthy volunteers without a history of rheumatic or chronic inflammatory disease. All participants will undergo a single, non-invasive skin autofluorescence measurement to assess advanced glycation end-product (AGE) accumulation.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis (RA, Ankylosing Spondylitis, Psoriatic Arthritis, Reactive Arthritis (ReA), Crystal Arthropathies, Connective Tissue Diseases
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Arthritis, Reactive, Crystal Arthropathies, Connective Tissue Diseases, Familial Mediterranean Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Skin Autofluorescence-Derived Advanced Glycation End Product Level
Advanced glycation end-product (AGE) accumulation assessed non-invasively by skin autofluorescence measurement using a validated AGE Reader device, expressed in arbitrary units (AU).
Measured: Baseline (single study visit)
Secondary outcomes (2)
Comparison of AGE Levels Between Rheumatic Disease Subtypes
Comparison of skin autofluorescence-derived advanced glycation end-product (AGE) levels among different rheumatic disease subgroups and healthy controls.
Measured: Baseline (single study visit)
Association Between AGE Levels and Inflammatory Markers
Association between skin autofluorescence-derived AGE levels and systemic inflammatory markers, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis (RAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Taner Dandinoğlu, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329556
- Sponsor's protocol ID
- 2026-Rheumatology-1
- Status last verified
- Jan 2026
- First submitted
- 28 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Groot L, Hinkema H, Westra J, Smit AJ, Kallenberg CG, Bijl M, Posthumus MD. Advanced glycation endproducts are increased in rheumatoid arthritis patients with controlled disease. Arthritis Res Ther. 2011;13(6):R205. doi: 10.1186/ar3538. Epub 2011 Dec 14.
PubMed 22168993
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Advanced Glycation End Products Accumulation in Rheumatic Diseases Using Non-Invasive Skin Autofluorescence Measurements
- ClinicalTrials.gov ID
- NCT07329556
- Acronym / sponsor ID
- 2026-Rheumatology-1
- Conditions
- Rheumatoid Arthritis (RA, Ankylosing Spondylitis, Psoriatic Arthritis, Reactive Arthritis (ReA), Crystal Arthropathies, Connective Tissue Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 to 75 years diagnosed with inflammatory rheumatic diseases who are followed at a tertiary rheumatology outpatient clinic, as well as age- and sex-matched healthy volunteers without a history of rheumatic or chronic inflammatory disease. All participants will undergo a single, non-invasive skin autofluorescence measurement to assess advanced glycation end-product (AGE) accumulation.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
Comparison of AGE Levels Between Rheumatic Disease Subtypes
Time frame: Baseline (single study visit)
Association Between AGE Levels and Inflammatory Markers
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Results publication: PubMed 22168993de Groot L, Hinkema H, Westra J, Smit AJ, Kallenberg CG, Bijl M, Posthumus MD. Advanced glycation endproducts are increased in rheumatoid arthritis patients with controlled disease. Arthritis Res Ther. 2011;13(6):R205. doi: 10.1186/ar3538. Epub 2011 Dec 14.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA and Ankylosing Spondylitis, run by Bursa City Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Altuğ Güner, MD (+905337414088, altugguner555@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Autofluorescence-Derived Advanced Glycation End Product Level (time frame: Baseline (single study visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07329556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.