NCT07329556

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Jan 2026Apr 2027

First Submitted

Initial submission to the registry

December 28, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2027

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

December 28, 2025

Last Update Submit

January 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline (single study visit)

Secondary Outcomes (2)

  • Comparison of AGE Levels Between Rheumatic Disease Subtypes

    Baseline (single study visit)

  • Association Between AGE Levels and Inflammatory Markers

    Baseline

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Arthritis, RheumatoidSpondylitis, AnkylosingArthritis, PsoriaticArthritis, ReactiveCrystal ArthropathiesConnective Tissue DiseasesFamilial Mediterranean Fever

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesAxial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesAnkylosisPsoriasisSkin Diseases, PapulosquamousSkin DiseasesArthritis, InfectiousInfectionsPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Altuğ Güner, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2025

First Posted

January 9, 2026

Study Start

January 15, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

April 15, 2027

Last Updated

January 9, 2026

Record last verified: 2026-01