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

NCT07453290 | Not Yet Recruiting

• 1 other identifier: TKD-GER-2026-02
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Autoimmune Thyroiditis

Keywords

Hashimoto Disease

Outcome Measures

Primary Outcomes (1)

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

  Baseline

Study Arms (2)

Hashimoto Disease

Adults aged 18-65 years diagnosed with Hashimoto's thyroiditis based on clinical evaluation, thyroid function tests, and positive anti-thyroid peroxidase (anti-TPO) and/or anti-thyroglobulin (anti-TG) antibodies. Participants may be euthyroid or hypothyroid. Serum soluble α-Klotho and FGF23 levels will be measured. Clinical, inflammatory, renal, and mineral metabolism parameters will be recorded.

Other: Blood Sampling and Biomarker Measurement

Healthy Controls

Age- and sex-matched adults without a history of thyroid disease, autoimmune disorders, chronic kidney disease, or chronic systemic illness. Participants will have normal thyroid function tests. Serum soluble α-Klotho and FGF23 levels will be measured, and clinical laboratory parameters will be recorded for comparison.

Other: Blood Sampling and Biomarker Measurement

Interventions

Blood Sampling and Biomarker Measurement OTHER

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.

Hashimoto Disease; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

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)

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead

MeSH Terms

Conditions

Thyroiditis, Autoimmune; Hashimoto Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 5, 2026
• Study Start: March 2, 2026
• Primary Completion: May 20, 2026
• Study Completion: May 20, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share