NCT07616570Completed
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
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 88 (actual)
- First submitted
- 21 May 2026
- Start date
- 10 Dec 2025
- Primary completion date
- 16 Apr 2026
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Diseases
- Obesity
- NCT number
- NCT07616570
What you commit to
- Study type: Observational
- Participants enrolled: 88
- From 10 Dec 2025 to the primary completion date, 16 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous thyroid hormone replacement therapy
Other illness
- Known hypothalamic or pituitary disease
- History of thyroid surgery or radioactive iodine therapy
- Active malignancy
- Acute or chronic inflammatory disease
- Severe hepatic or renal disease
- Diabetes mellitus
Lab values
- Use of medications known to significantly affect thyroid function, glucose metabolism, lipid metabolism, or adipokine levels
Other
- Pregnancy or lactation
- Menopause
- Inability or unwillingness to provide informed consent or comply with follow-up requirements
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Health Sciences Basaksehir Cam and Sakura City Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.