AGE and CALLY Index in Familial Mediterranean Fever
ConditionFamilial Mediterranean Fever
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorBursa City Hospital
About this trial
Familial Mediterranean Fever (FMF) is an autoinflammatory disease characterized by recurrent inflammatory attacks and persistent low-grade inflammation. Even during attack-free periods, subclinical inflammation may continue and contribute to long-term complications.
Advanced glycation end products (AGEs) are molecules that accumulate under chronic inflammatory and oxidative stress conditions. AGEs can be measured non-invasively using skin autofluorescence (SAF). The C-reactive protein-albumin-lymphocyte (CALLY) index is a composite marker derived from routine laboratory parameters and reflects systemic inflammation and nutritional status.
This observational cross-sectional study aims to evaluate the association between skin autofluorescence-measured AGE levels and the CALLY index in patients with FMF. The study will also compare AGE levels between FMF patients and age- and sex-matched healthy controls.
The study does not involve any intervention, treatment assignment, or randomization. All laboratory parameters will be obtained from routine clinical evaluations, and AGE measurement will be performed using a non-invasive device.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 18 and 65 years
Diagnosis of Familial Mediterranean Fever according to Tel-Hashomer criteria
At least 6 months of clinical follow-up
Available routine laboratory data (CRP, albumin, lymphocyte count)
Disqualifiers
Diagnosis of diabetes mellitus
Chronic kidney disease stage 3 or higher
Active infection
Malignancy within the past 5 years
Trial population
Adult patients diagnosed with Familial Mediterranean Fever and age- and sex-matched healthy volunteers recruited from a single tertiary care center.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Skin Autofluorescence Measurement
DeviceNon-invasive measurement of advanced glycation end products (AGE) using skin autofluorescence technology. The assessment is performed once at baseline using a validated optical device applied to the volar side of the forearm. The procedure is painless, requires no blood sampling, and does not involve any therapeutic intervention or treatment assignment.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Familial Mediterranean Fever Patients1 intervention
Group B: Healthy Controls1 intervention
Trial outcomes
Primary outcomes
1
Correlation Between Skin Autofluorescence-Measured AGE Levels and CALLY Index
Assessment of the association between advanced glycation end products (AGE) levels measured by skin autofluorescence and the C-reactive protein-albumin-lymphocyte (CALLY) index in patients with Familial Mediterranean Fever.
Time frame
BaselineSecondary outcomes
1
Comparison of AGE Levels Between FMF Patients and Healthy Controls
Comparison of skin autofluorescence-measured advanced glycation end product (AGE) levels between Familial Mediterranean Fever patients and age- and sex-matched healthy controls.
Time frame
Baseline2
Association Between AGE Levels and Inflammatory Parameters
Evaluation of the relationship between AGE levels and inflammatory markers including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and serum amyloid A (SAA).
Time frame
Baseline3
Association Between AGE Levels and Metabolic Parameters
Assessment of the association between AGE levels and metabolic markers including HbA1c and lipid profile (total cholesterol, HDL, LDL).
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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