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

Completed

• Conditions: Ailesel Akdeniz Ateşi

• Registration Number: NCT06451471
• Lead Sponsor: Turkish League Against Rheumatism

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-04
• Last Update Submitted: 2024-06-04
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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:
  <!-- -->
  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. -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum Galectin-3 Levels	2022	Comparison of serum Galectin-3 levels between FMF patients and healthy controls to determine if there is a significant difference.

Secondary Outcome Measures

Name	Time	Method
Serum Amyloid A (SAA) Levels	2022	Measurement of SAA levels in both FMF patients and healthy controls.
Clinical Variables	2022	Analysis of the relationship between Galectin-3/SAA levels and clinical variables such as age, BMI, disease duration, and frequency of FMF attacks.
Correlation Analysis	2022	Determination of the correlation between serum Galectin-3 levels and SAA levels in FMF patients.

Trial Locations

Locations (1)

Ataturk University Faculty of Medicine; 🇹🇷 Erzurum, Turkey