"Galectin-3 as a Marker of Subclinical Inflammation in FMF"

Turkish League Against Rheumatism

Status: Completed

Conditions: Ailesel Akdeniz Ateşi

Study type: Observational

Funder types: Other

Identifiers

NCT06451471

TRASD-OL-TEZ

Details and patient eligibility

About

The goal of this observational study is to learn about the relationship between serum Galectin-3 levels and subclinical inflammation in patients with Familial Mediterranean Fever (FMF). The main questions it aims to answer are:

• Are serum Galectin-3 levels higher in FMF patients compared to healthy controls?
• Is there a positive correlation between serum Galectin-3 levels and Serum Amyloid A (SAA) protein levels in FMF patients?

Participants will:

• Provide blood samples to measure serum Galectin-3 and SAA levels.
• Complete a sociodemographic and clinical data form.
• Fill out the FMF Quality of Life (QoL) scale.

Researchers will compare FMF patients and healthy controls to see if there are significant differences in serum Galectin-3 levels and to determine the correlation between Galectin-3 and SAA protein levels in FMF patients.

Enrollment: 154 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• for the Patient Group:

  1. Aged between 18 and 65 years,

  2. Able to provide written informed consent for the study,

  3. Literate,

  4. Diagnosed with Familial Mediterranean Fever (FMF) according to the Tel Hashomer criteria and not currently experiencing an attack (with at least 15 days since the last attack).

     • Inclusion Criteria for the Healthy Control Group:
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  1. Aged between 18 and 65 years,
  2. Able to provide written informed consent for the study,
  3. Literate.

Exclusion criteria

• Exclusion Criteria for the Patient Group:

  1. Presence of known inflammatory diseases other than FMF,
  2. Presence of known systemic, chronic, severe medical conditions,
  3. Presence of active infection,
  4. Conditions affecting cognitive functions such as mental retardation, delirium, dementia, epilepsy, and alcohol or substance use disorders,
  5. Being pregnant or in the lactation period.

• Exclusion Criteria for the Healthy Control Group:

  1. Presence of known systemic, chronic, severe medical conditions,
  2. Presence of inflammatory diseases,
  3. Presence of active infection,
  4. Conditions affecting cognitive functions such as mental retardation, delirium, dementia, epilepsy, and alcohol or substance use disorders,
  5. Being pregnant or in the lactation period. -

Trial design

154 participants in 2 patient groups

Active Comparator: Group 1

Description:

PATIENT GROUP DIAGNOSED WITH FMF

Active Comparator: Group 2

Description:

HEALTHY CONTROL GROUP