Clinical trial NCT06451471: "Galectin-3 as a Marker of Subclinical Inflammation in FMF"
Official title: Assessment of Serum Galectin-3 Level as an Indicator of Subclinical Inflammation in Patients With Familial Mediterranean Fever
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ailesel Akdeniz Ateşi
Keywords: GALEKTİN-3
Subclinical Inflammation
Lead sponsor: Turkish League Against Rheumatism
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief summary: 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.


Eligibility criteria: 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. -

Primary outcomes:
measure: Serum Galectin-3 Levels
timeFrame: 2022
Secondary outcomes:
measure: Serum Amyloid A (SAA) Levels
timeFrame: 2022
measure: Correlation Analysis
timeFrame: 2022
measure: Clinical Variables
timeFrame: 2022
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Faculty of Medicine
Study officials:
References: