[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627796":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":16,"studyPopulation":17,"armGroups":18,"interventions":28,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":33,"collaborators":11,"id":35,"slug":11,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":40,"eligibilityCriteria":41,"healthyVolunteers":36,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":11,"studyType":48,"phases":11,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":53,"whyStopped":11,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":59,"leadSponsor":61,"locationsCount":11},{"fullName":5,"class":6},"Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Difference in Serum Soluble α-Klotho Levels Between Hashimoto's Thyroiditis and Healthy Controls",null,"Baseline",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":14,"timePerspective":15,"maskingInfo":11},"CASE_CONTROL","PROSPECTIVE","Hashimoto's thyroiditis (HT) is a chronic autoimmune disease characterized by lymphocytic infiltration of the thyroid gland and the presence of anti-thyroid peroxidase (anti-TPO) and anti-thyroglobulin (anti-TG) antibodies. While traditionally defined by thyroid hormone dysfunction, emerging evidence suggests that HT is associated with persistent immune activation, oxidative stress, and low-grade systemic inflammation.\n\nThe α-Klotho-FGF23 axis is an endocrine pathway involved in phosphate metabolism, vitamin D regulation, inflammation, and aging-related biological processes. Soluble α-Klotho (sKlotho) exerts anti-inflammatory and anti-oxidative effects, whereas FGF23 is increasingly recognized as a hormone influenced by inflammatory stimuli. Dysregulation of this axis has been reported in various chronic inflammatory conditions; however, data in autoimmune thyroid disease are limited.\n\nThis prospective, single-center case-control study will include adult patients with Hashimoto's thyroiditis and healthy controls without thyroid or systemic autoimmune disease. Serum soluble α-Klotho and FGF23 levels will be measured using enzyme-linked immunosorbent assay (ELISA). Clinical data including thyroid function tests (TSH, free T4), thyroid autoantibodies (anti-TPO, anti-TG), renal function parameters, mineral metabolism markers (calcium, phosphorus, 25-hydroxyvitamin D), and C-reactive protein (CRP) will be recorded.\n\nPrimary analyses will compare sKlotho and FGF23 levels between groups. Secondary analyses will evaluate associations between these biomarkers and autoimmune burden (anti-TG levels), inflammatory status (CRP), and thyroid function. Multivariable regression models will be used to determine independent associations after adjustment for potential confounders.\n\nThe study also aims to evaluate the FGF23\u002FsKlotho ratio as an integrated indicator of functional imbalance within the Klotho-FGF23 axis in Hashimoto's thyroiditis.","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.",[19,24],{"label":20,"type":11,"description":21,"interventionNames":22},"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\u002For 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.",[23],"Other: Blood Sampling and Biomarker Measurement",{"label":25,"type":11,"description":26,"interventionNames":27},"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.",[23],[29],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"Blood Sampling and Biomarker Measurement","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.",[20,25],{"type":34,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100627796",false,"NCT07453290","Dysregulation of the Soluble α-Klotho-FGF23 Axis in Hashimoto's Thyroiditis: A Case-Control Study","The KLASH Study: Dysregulation of the Soluble α-Klotho-FGF23 Axis in Hashimoto's Thyroiditis - A Prospective Case-Control Study","klofgfhashi","Inclusion Criteria:\n\nAdults aged 18-65 years\n\nAbility to provide written informed consent\n\nHashimoto group: Diagnosis of Hashimoto's thyroiditis based on positive anti-thyroid peroxidase (anti-TPO) and\u002For anti-thyroglobulin (anti-TG) antibodies with compatible clinical\u002Fultrasound findings (as available)\n\nControl group: No history of thyroid disease or autoimmune disease; normal thyroid function tests (TSH and free T4 within reference range)\n\nExclusion Criteria:\n\nPregnancy or breastfeeding\n\nKnown chronic kidney disease (eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m²)\n\nActive infection or acute inflammatory condition within the past 4 weeks\n\nKnown malignancy under active treatment\n\nChronic inflammatory\u002Fautoimmune disease other than Hashimoto's thyroiditis (e.g., rheumatoid arthritis, SLE, IBD)\n\nUse of systemic glucocorticoids or immunosuppressive therapy within the past 3 months\n\nKnown parathyroid disease or disorders of calcium\u002Fphosphate metabolism\n\nCurrent use of medications strongly affecting mineral metabolism (e.g., phosphate binders, active vitamin D analogs)","ALL","18 Years","80 Years",{"count":46,"type":47},150,"ESTIMATED","OBSERVATIONAL","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.\n\nThis 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\u002FsKlotho ratio will be evaluated as an integrated marker of functional imbalance within the Klotho-FGF23 axis.\n\nThe 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.",[51],"Autoimmune Thyroiditis",[20],"NOT_YET_RECRUITING","2026-03-02",{"date":56,"type":57},"2026-03-05","ACTUAL",{"date":54,"type":47},{"date":60,"type":47},"2026-05-20",{"name":5,"class":6}]