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

Starting soon

Conditions studied: Autoimmune Thyroiditis

In brief

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.

Key facts

Study ID

NCT07453290

Run by

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

People needed

150

Starts

2026-03-02

Expected to finish

2026-05-20

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18-65 years
• Ability to provide written informed consent
• Hashimoto group: Diagnosis of Hashimoto's thyroiditis based on positive anti-thyroid peroxidase (anti-TPO) and/or anti-thyroglobulin (anti-TG) antibodies with compatible clinical/ultrasound findings (as available)
• Control group: No history of thyroid disease or autoimmune disease; normal thyroid function tests (TSH and free T4 within reference range)

You may not qualify if…

• Pregnancy or breastfeeding
• Known chronic kidney disease (eGFR < 60 mL/min/1.73 m²)
• Active infection or acute inflammatory condition within the past 4 weeks
• Known malignancy under active treatment
• Chronic inflammatory/autoimmune disease other than Hashimoto's thyroiditis (e.g., rheumatoid arthritis, SLE, IBD)
• Use of systemic glucocorticoids or immunosuppressive therapy within the past 3 months
• Known parathyroid disease or disorders of calcium/phosphate metabolism
• Current use of medications strongly affecting mineral metabolism (e.g., phosphate binders, active vitamin D analogs)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.