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

NCT07616570 | Completed

• 1 other identifier: IRB-2026-32
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypothyroidism; Primary Hypothyroidism; Metabolic Syndrome

Keywords

Primary Hypothyroidism; Adipokines; Asprosin; Adipolin; Omentin-1; Visfatin; Metabolic Remodeling; Adipose Tissue; Obesity Phenotype; Insulin Resistance; Cardiometabolic Risk; HOMA-IR; TyG Index; Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Change in Serum Adipokine Levels 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

University of Health Sciences Basaksehir Cam and Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fasting venous blood serum samples collected before treatment initiation and after 8 weeks of levothyroxine replacement therapy will be retained at -80°C for adipokine and metabolic biomarker analyses. Retained serum samples include specimens used for measurement of asprosin, adipolin, omentin-1, visfatin, and additional metabolic parameters.

MeSH Terms

Conditions

Hypothyroidism; Metabolic Syndrome; Arachnodactyly; Insulin Resistance; Dyslipidemias

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipid Metabolism Disorders

Study Officials

• Esra Beslendi, MD

  University of Health Sciences, Basaksehir Cam and Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Internal Medicine

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 1, 2026
• Study Start: December 10, 2025
• Primary Completion: April 16, 2026
• Study Completion: April 16, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)