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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Istanbul, Turecko (Türkiye), 34480
- University of Health Sciences Basaksehir Cam and Sakura City Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Serum Adipokine Levels After Levothyroxine Replacement Therapy
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Esra Beslendi, MD, University of Health Sciences, Basaksehir Cam and Sakura City Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Onemocnění endokrinního systému
- Nemoci pohybového aparátu
- Metabolické choroby
- Poruchy metabolismu glukózy
- Muskuloskeletální abnormality
- Vrozené vady
- Hyperinzulinismus
- Poruchy metabolismu lipidů
- Onemocnění štítné žlázy
- Deformace končetin, vrozené
- Vrozené, dědičné a neonatální nemoci a abnormality
- Nutriční a metabolické nemoci
- Metabolický syndrom
- Rezistence na inzulín
- Dyslipidemie
- Hypotyreóza
- Arachnodaktylie
Další identifikační čísla studie
- IRB-2026-32
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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