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.
Przegląd badań
Status
Szczegółowy opis
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 studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Istanbul, Turcja (Türkiye), 34480
- University of Health Sciences Basaksehir Cam and Sakura City Hospital
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Serum Adipokine Levels After Levothyroxine Replacement Therapy
Ramy czasowe: Baseline and 8 weeks after levothyroxine replacement therapy
|
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.
|
Baseline and 8 weeks after levothyroxine replacement therapy
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Esra Beslendi, MD, University of Health Sciences, Basaksehir Cam and Sakura City Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu hormonalnego
- Choroby układu mięśniowo-szkieletowego
- Choroby metaboliczne
- Zaburzenia metabolizmu glukozy
- Nieprawidłowości mięśniowo-szkieletowe
- Wady wrodzone
- Hiperinsulinizm
- Zaburzenia metabolizmu lipidów
- Choroby tarczycy
- Deformacje kończyn, wrodzone
- Wrodzone, dziedziczne i noworodkowe choroby i nieprawidłowości
- Choroby żywieniowe i metaboliczne
- Syndrom metabliczny
- Insulinooporność
- Dyslipidemie
- Niedoczynność tarczycy
- Arachnodaktylia
Inne numery identyfikacyjne badania
- IRB-2026-32
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .