AGE and CALLY Index in Familial Mediterranean Fever

NCT07439341 | Not Yet Recruiting

• 1 other identifier: 2026rheumotology-3
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Familial Mediterranean Fever

Keywords

Advanced Glycation End Products; Skin Autofluorescence; CALLY Index; Amyloidosis; Inflammatory Biomarkers

Outcome Measures

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.

  Baseline

Secondary Outcomes (3)

• Comparison of AGE Levels Between FMF Patients and Healthy Controls

  Baseline

• Association Between AGE Levels and Inflammatory Parameters

  Baseline

• Association Between AGE Levels and Metabolic Parameters

  Baseline

Study Arms (2)

Familial Mediterranean Fever Patients

Patients aged 18-65 years diagnosed with Familial Mediterranean Fever according to Tel-Hashomer criteria. Participants will undergo a single non-invasive skin autofluorescence measurement for assessment of advanced glycation end products (AGE). Routine laboratory parameters will be used to calculate the CALLY index. No intervention or treatment assignment will be performed.

Device: Skin Autofluorescence Measurement

Healthy Controls

Age- and sex-matched healthy volunteers without chronic inflammatory or metabolic disease. Participants will undergo a single non-invasive skin autofluorescence measurement for assessment of advanced glycation end products (AGE). No intervention or treatment assignment will be performed.

Device: Skin Autofluorescence Measurement

Interventions

Skin Autofluorescence Measurement DEVICE

Non-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.

Also known as: AGE Reader

Familial Mediterranean Fever Patients; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with Familial Mediterranean Fever and age- and sex-matched healthy volunteers recruited from a single tertiary care center.

You may qualify if:

• For FMF Patients:
• 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)
• Not in an acute FMF attack at the time of assessment
• Ability to provide written informed consent
• For Healthy Controls:
• Age between 18 and 65 years
• No history of chronic inflammatory, autoimmune, metabolic, or renal disease
• Ability to provide written informed consent

You may not qualify if:

• Diagnosis of diabetes mellitus
• Chronic kidney disease stage 3 or higher
• Active infection
• Malignancy within the past 5 years
• Dermatologic condition affecting the forearm measurement site
• Use of high-dose antioxidant or vitamin supplementation within the past 3 months
• Any condition that, in the opinion of the investigators, may interfere with study participation

Sponsors & Collaborators

• Bursa City Hospital: lead

MeSH Terms

Conditions

Familial Mediterranean Fever; Amyloidosis

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

altuğ güner

CONTACT

02249750000; altugguner555@gmail.com

Study Design

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

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02