Serum Adipokines and Metabolic Parameters With Hormone Replacement in Newly Diagnosed Hypothyroidism (NCT07616570) | Clinical Trial Compass
CompletedNot Applicable
Serum Adipokines and Metabolic Parameters With Hormone Replacement in Newly Diagnosed Hypothyroidism
Turkey (Türkiye)88 participantsStarted 2025-12-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Serum Adipokine Levels After Levothyroxine Replacement Therapy
Timeframe: Baseline and 8 weeks after levothyroxine replacement therapy