Serum Adipokines and Metabolic Parameters With Hormone Replacement in Newly Diagnosed Hypothyroidism
Hormonal Normalization Is Not Metabolic Recovery: Adipokine Dynamics After Levothyroxine Replacement in Newly Diagnosed Primary Hypothyroidism
Primary hypothyroidism is associated with significant metabolic disturbances, including dyslipidemia, insulin resistance, adipose tissue dysfunction, and altered adipokine secretion. Although levothyroxine replacement therapy effectively restores thyroid hormone levels, the extent to which biochemical recovery reflects metabolic improvement remains unclear.
This prospective observational study aims to evaluate changes in serum adipokine levels, including asprosin, adipolin, omentin-1, and visfatin, together with metabolic parameters in newly diagnosed primary hypothyroid patients before and after 8 weeks of levothyroxine replacement therapy. In addition to conventional biochemical markers, multiple cardiometabolic indices related to insulin resistance, lipid metabolism, and hepatic metabolic burden will be analyzed.
The study is designed to investigate whether normalization of thyroid function is accompanied by parallel metabolic recovery and to explore the potential role of adipokine dynamics in adipose-metabolic remodeling during early levothyroxine treatment.
Panoramica dello studio
Stato
Descrizione dettagliata
Hypothyroidism is associated with multiple cardiometabolic abnormalities, including dyslipidemia, insulin resistance, adipose tissue dysfunction, altered energy homeostasis, and chronic low-grade inflammation. Although levothyroxine replacement therapy is effective in restoring thyroid hormone levels, metabolic recovery may not occur simultaneously with biochemical normalization of thyroid function.
Adipokines are biologically active molecules secreted by adipose tissue and play important roles in glucose metabolism, lipid regulation, inflammation, and cardiometabolic risk. Among these adipokines, asprosin, adipolin, omentin-1, and visfatin have been associated with insulin resistance, obesity-related metabolic dysfunction, hepatic metabolism, and inflammatory pathways. However, data regarding the dynamic changes of these adipokines after levothyroxine replacement in newly diagnosed primary hypothyroidism remain limited and inconsistent.
This prospective observational study was designed to evaluate changes in serum adipokine levels and metabolic parameters before and after levothyroxine replacement therapy in newly diagnosed primary hypothyroid patients. Serum samples and metabolic measurements will be obtained before treatment initiation and after 8 weeks of levothyroxine therapy.
In addition to conventional thyroid function tests, multiple metabolic indices associated with insulin resistance, lipid metabolism, hepatosteatosis, and cardiometabolic risk will be analyzed, including HOMA-IR, TyG index, METS-IR, AIP, HSI, and Castelli risk indices.
The primary objective of the study is to evaluate changes in adipokine levels following levothyroxine replacement therapy. Secondary objectives include assessing the relationship between adipokine dynamics and metabolic remodeling, insulin resistance, lipid metabolism, obesity phenotype, and hepatic metabolic burden during early biochemical recovery.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Istanbul, Turchia (Türkiye), 34480
- University of Health Sciences Basaksehir Cam and Sakura City Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Female patients aged 18 years or older
- Premenopausal status
- Newly diagnosed primary hypothyroidism, defined by elevated serum TSH level above the reference range with low free T4 level
- No previous use of levothyroxine or other thyroid hormone replacement therapy
- Ability and willingness to provide written informed consent
- Completion of both baseline and 8-week follow-up assessments
Exclusion Criteria:
- Known hypothalamic or pituitary disease
- Previous thyroid hormone replacement therapy
- Pregnancy or lactation
- Menopause
- History of thyroid surgery or radioactive iodine therapy
- Active malignancy
- Acute or chronic inflammatory disease
- Severe hepatic or renal disease
- Diabetes mellitus
- Use of medications known to significantly affect thyroid function, glucose metabolism, lipid metabolism, or adipokine levels
- Inability or unwillingness to provide informed consent or comply with follow-up requirements
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Newly Diagnosed Primary Hypothyroidism Cohort
Participants in this prospective observational cohort are newly diagnosed primary hypothyroid patients who have not previously received levothyroxine or other thyroid hormone replacement therapy.
All participants will receive standard-of-care levothyroxine treatment according to routine clinical practice.
Clinical, biochemical, metabolic, and adipokine measurements will be obtained before treatment initiation and after 8 weeks of therapy.
Serum adipokines including asprosin, adipolin, omentin-1, and visfatin will be analyzed together with metabolic and cardiometabolic parameters.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in Serum Adipokine Levels After Levothyroxine Replacement Therapy
Lasso di tempo: Baseline and 8 weeks after levothyroxine replacement therapy
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Serum adipokine levels, including asprosin, adipolin, omentin-1, and visfatin, will be measured before treatment initiation and after 8 weeks of standard-of-care levothyroxine replacement therapy in newly diagnosed primary hypothyroid patients.
Changes in adipokine concentrations will be evaluated to assess early adipose-metabolic remodeling during biochemical thyroid recovery.
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Baseline and 8 weeks after levothyroxine replacement therapy
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Esra Beslendi, MD, University of Health Sciences, Basaksehir Cam and Sakura City Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema endocrino
- Malattie muscoloscheletriche
- Malattie metaboliche
- Disturbi del metabolismo del glucosio
- Anomalie muscoloscheletriche
- Anomalie congenite
- Iperinsulinismo
- Disturbi del metabolismo lipidico
- Malattie della tiroide
- Deformità degli arti, congenite
- Malattie e anomalie congenite, ereditarie e neonatali
- Malattie nutrizionali e metaboliche
- Sindrome metabolica
- Resistenza all'insulina
- Dislipidemie
- Ipotiroidismo
- Aracnodattilia
Altri numeri di identificazione dello studio
- IRB-2026-32
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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