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OpenTrials
Completed

NCT Number: NCT06451471

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

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.

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Key information

Conditions

Ailesel Akdeniz Ateşi

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ataturk University Faculty of Medicine

Erzurum, 25240, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • for the Patient Group:
  • Aged between 18 and 65 years,
  • Able to provide written informed consent for the study,
  • Literate,
  • 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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  • Aged between 18 and 65 years,
  • Able to provide written informed consent for the study,
  • Literate.

Exclusion criteria

  • Exclusion Criteria for the Patient Group:
  • Presence of known inflammatory diseases other than FMF,
  • Presence of known systemic, chronic, severe medical conditions,
  • Presence of active infection,
  • Conditions affecting cognitive functions such as mental retardation, delirium, dementia, epilepsy, and alcohol or substance use disorders,
  • Being pregnant or in the lactation period.
  • Exclusion Criteria for the Healthy Control Group:
  • Presence of known systemic, chronic, severe medical conditions,
  • Presence of inflammatory diseases,
  • Presence of active infection,
  • Conditions affecting cognitive functions such as mental retardation, delirium, dementia, epilepsy, and alcohol or substance use disorders,
  • Being pregnant or in the lactation period. -

Treatment and study plan

Primary outcomes

  1. Serum Galectin-3 Levels

    Time frame: 2022

    Comparison of serum Galectin-3 levels between FMF patients and healthy controls to determine if there is a significant difference.

Secondary outcomes

  1. Serum Amyloid A (SAA) Levels

    Time frame: 2022

    Measurement of SAA levels in both FMF patients and healthy controls.

  2. Correlation Analysis

    Time frame: 2022

    Determination of the correlation between serum Galectin-3 levels and SAA levels in FMF patients.

  3. Clinical Variables

    Time frame: 2022

    Analysis of the relationship between Galectin-3/SAA levels and clinical variables such as age, BMI, disease duration, and frequency of FMF attacks.

Sponsors and collaborators

Lead sponsor

Turkish League Against Rheumatism

Other

Registry information

Official study title

Assessment of Serum Galectin-3 Level as an Indicator of Subclinical Inflammation in Patients With Familial Mediterranean Fever

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.