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

NCT06451471 | Completed

• 1 other identifier: TRASD-OL-TEZ
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Ailesel Akdeniz Ateşi

Keywords

GALEKTİN-3; Subclinical Inflammation

Outcome Measures

Primary Outcomes (1)

• Serum Galectin-3 Levels

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

  2022

Secondary Outcomes (3)

• Serum Amyloid A (SAA) Levels

  2022

• Correlation Analysis

  2022

• Clinical Variables

  2022

Study Arms (2)

Active Comparator: Group 1

PATIENT GROUP DIAGNOSED WITH FMF

Active Comparator: Group 2

HEALTHY CONTROL GROUP

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

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).

You may qualify if:

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

You may not qualify if:

• 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.
• 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. -

Sponsors & Collaborators

• Turkish League Against Rheumatism: lead

Study Sites (1)

Ataturk University Faculty of Medicine

Erzurum, 25240, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 11, 2024
• Study Start: May 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

TU (1)