このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Serum Adipokines and Metabolic Parameters With Hormone Replacement in Newly Diagnosed Hypothyroidism

2026年5月27日 更新者:Esra Beslendi、Başakşehir Çam & Sakura City Hospital

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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (実際)

88

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Istanbul、トルコ(Türkiye)、34480
        • University of Health Sciences Basaksehir Cam and Sakura City Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

The study population consists of premenopausal female patients aged 18 years or older who were newly diagnosed with primary hypothyroidism at the Internal Medicine outpatient clinic and had not previously received levothyroxine or any other thyroid hormone replacement therapy. Participants were evaluated before treatment initiation and after 8 weeks of standard-of-care levothyroxine replacement therapy. Only patients who completed both baseline and follow-up assessments were included in the final analysis.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Serum Adipokine Levels After Levothyroxine Replacement Therapy
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Esra Beslendi, MD、University of Health Sciences, Basaksehir Cam and Sakura City Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年12月10日

一次修了 (実際)

2026年4月16日

研究の完了 (実際)

2026年4月16日

試験登録日

最初に提出

2026年5月21日

QC基準を満たした最初の提出物

2026年5月27日

最初の投稿 (実際)

2026年6月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月1日

QC基準を満たした最後の更新が送信されました

2026年5月27日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Individual participant data (IPD) are not planned to be shared due to institutional and ethical restrictions related to patient confidentiality and biospecimen-based clinical data.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する