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

May 27, 2026 updated by: 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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34480
        • University of Health Sciences Basaksehir Cam and Sakura City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum Adipokine Levels After Levothyroxine Replacement Therapy
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Başakşehir Çam & Sakura City Hospital

Investigators

  • Principal Investigator: Esra Beslendi, MD, University of Health Sciences, Basaksehir Cam and Sakura City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2025

Primary Completion (Actual)

April 16, 2026

Study Completion (Actual)

April 16, 2026

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 27, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2026-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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