Dysregulation of the Soluble α-Klotho-FGF23 Axis in Hashimoto's Thyroiditis: A Case-Control Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

About this trial

Hashimoto's thyroiditis (HT) is the most common autoimmune thyroid disease and is increasingly recognized as a condition associated with chronic low-grade systemic inflammation beyond thyroid hormone dysfunction. The soluble α-Klotho-fibroblast growth factor 23 (FGF23) axis plays a central role in mineral metabolism, inflammation, and aging-related pathways; however, its involvement in HT has not been adequately characterized.

This prospective case-control study aims to compare serum soluble α-Klotho and FGF23 levels between adults with Hashimoto's thyroiditis and age- and sex-matched healthy controls, and to investigate their associations with thyroid function parameters, inflammatory markers, and autoimmune burden. In addition, the FGF23/sKlotho ratio will be evaluated as an integrated marker of functional imbalance within the Klotho-FGF23 axis.

The study seeks to determine whether Hashimoto's thyroiditis is associated with systemic dysregulation of the Klotho-FGF23 pathway independent of renal function and mineral metabolism.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Adult participants aged 18-65 years will be recruited from the endocrinology outpatient clinic of a tertiary care center. The study population will consist of patients diagnosed with Hashimoto's thyroiditis and age- and sex-matched healthy controls without thyroid or systemic autoimmune disease. All participants will undergo baseline clinical evaluation and venous blood sampling for measurement of soluble α-Klotho and FGF23 levels, along with routine laboratory parameters.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Blood Sampling and Biomarker Measurement

    Other intervention

    Venous blood sampling for measurement of serum soluble α-Klotho and fibroblast growth factor 23 (FGF23) levels using enzyme-linked immunosorbent assay (ELISA). No therapeutic intervention is administered.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Hashimoto Disease1 intervention
Group B: Healthy Controls1 intervention

Trial outcomes

Primary outcomes

1

Difference in Serum Soluble α-Klotho Levels Between Hashimoto's Thyroiditis and Healthy Controls

Time frame
Baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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