Autoimmune ThyroiditisklofgfhashiNCT07453290
Dysregulation of the Soluble α-Klotho-FGF23 Axis in Hashimoto's Thyroiditis: A Case-Control Study
An observational study of Autoimmune Thyroiditis, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Autoimmune Thyroiditis
- What is being tested?
- Blood Sampling and Biomarker Measurement
- How many people
- 206 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2026to 20 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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 the reference range)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Kanuni Sultan Suleyman Training and Research Hospital
Istanbul
About this study
Official title: The KLASH Study: Dysregulation of the Soluble α-Klotho-FGF23 Axis in Hashimoto's Thyroiditis - A Prospective Case-Control Study
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.
Read the detailed description
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.
The 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.
This 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.
Primary 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.
The study also aims to evaluate the FGF23/sKlotho ratio as an integrated indicator of functional imbalance within the Klotho-FGF23 axis in Hashimoto's thyroiditis.
- Conditions
- Autoimmune Thyroiditis
- Being tested
- Blood Sampling and Biomarker Measurement
- Keywords
- Hashimoto Disease
- Medical subject headings
- Thyroiditis, Autoimmune, Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sampling and Biomarker MeasurementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Blood Sampling and Biomarker Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Serum Soluble α-Klotho Levels Between Hashimoto's Thyroiditis and Healthy Controls
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start2 Mar 2026
- Primary completion20 May 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune ThyroiditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- İrem Utku, Principal investigator, Tekirdağ Doktor İsmail Fehmi Cumalıoğlu City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453290
- Sponsor's protocol ID
- TKD-GER-2026-02
- Acronym
- klofgfhashi
- Status last verified
- Nov 2026
- First submitted
- 2 Mar 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The KLASH Study: Dysregulation of the Soluble α-Klotho-FGF23 Axis in Hashimoto's Thyroiditis - A Prospective Case-Control Study
- ClinicalTrials.gov ID
- NCT07453290
- Acronym / sponsor ID
- klofgfhashi / TKD-GER-2026-02
- Conditions
- Autoimmune Thyroiditis
- Keywords
- Hashimoto Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The 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.
This 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.
Primary 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.
The study also aims to evaluate the FGF23/sKlotho ratio as an integrated indicator of functional imbalance within the Klotho-FGF23 axis in Hashimoto's thyroiditis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hashimoto Disease | – | Other: Blood Sampling and Biomarker MeasurementAdults 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. |
| Healthy Controls | – | Other: Blood Sampling and Biomarker MeasurementAge- 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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 the reference range)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sampling and Biomarker MeasurementVenous 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. | Other | Hashimoto Disease, Healthy Controls |
Primary outcome
Difference in Serum Soluble α-Klotho Levels Between Hashimoto's Thyroiditis and Healthy Controls
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İrem Utku principal investigator
Tekirdağ Doktor İsmail Fehmi Cumalıoğlu City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Thyroiditis, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Serum Soluble α-Klotho Levels Between Hashimoto's Thyroiditis and Healthy Controls (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.