Impact of Subclinical Hypothyroidism on Liver Enzymes and Lipid Profile

NCT ID: NCT07236697

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

the goal of the randomized controlled observational study is to observe the effect of subclinical hypothyroidism on liver enzymes and lipid profile

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Subclinical hypothyroidism (SCH) is a prevalent endocrine disorder defined by elevated levels of thyroid-stimulating hormone (TSH) with normal concentrations of free thyroxine (T4) \[1\]. Despite its often-asymptomatic nature, SCH has been increasingly recognized for its association with a variety of metabolic abnormalities, with lipid profile disturbances being particularly notable\[2\].

The thyroid gland is one of the primary endocrine glands in human body and is in charge of the hormones triiodothyronine (T3) and thyroxine (T4). These hormones influence hepatic functions by regulating all cells' baseline metabolic rates, including hepatocytes. Therefore, any thyroid condition may impair liver function\[3\] .

sub clinical hypothyroidism is indicated by a moderate rise in TSH levels (TSH \> 4 mIU/l), along with normal thyroid hormone levels. Approximately 3% of the general population is affected by overt hypothyroidism. However, sub clinical hypothyroidism is found in 5-10% of the global population, as well as 8-10% of individuals aged over 65 years \[4\]. It should be noted that thyroid hormones have a crucial impact on multiple organs, especially the liver\[5\]. SCH is more common in women, the elderly, and individuals with a family history of diabetes and thyroid diseases (6, 7)SCH patients had significantly higher triglyceride (TG) levels (1.69 ± 1.9 vs. 1.45 ± 1.4) than the healthy population \[8\]. Another study by Sindhu and Vijay (9) suggested that SCH patients had more significant dyslipidemia than the euthyroid population, including total cholesterol(TC),very low-density lipoprotein cholesterol (VLDL-C), and low-density lipoprotein cholesterol (LDL-C).

Subclinical hypothyroidism (SCH) contributes to the progression of metabolic dysfunction-associated steatotic liver disease (MASLD) through several mechanisms \[10-12\]. One significant mechanism involves the activity of thyroid-stimulating hormone (TSH) on the cell membrane of hepatocytes, which disrupts triglyceride metabolism in the liver.

Additionally, atherogenic dyslipidemia is commonly observed in patients with hypothyroidism. The primary cause of hyperlipidemia associated with hypothyroidism is a decrease in cholesterol excretion and a significant rise in apoB lipoproteins. This is mainly due to insufficient breakdown and turnover of cholesterol, stemming from a reduction in the number of low-density lipoprotein (LDL) receptors present on the surface of hepatocytes

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Subclinical Hypothyroidism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

liver enzymes

subclinical hypothyroidism on liver enzymes and lipid profile

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* • Age ≥ 18 years

* For SCH group: Elevated TSH with normal FT4
* For control group: Normal TSH and FT4 levels

Exclusion Criteria

* • Evident hypothyroidism or hyperthyroidism

* Diagnosed with diabetes mellitus
* Chronic liver disease
* Chronic kidney disease
* Use of lipid-lowering or thyroid medications
* Pregnancy
* Alcohol abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shahd Ali Mohamed

resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Muhammad Abbas Said, professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut university hospitals

Asyut, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

shahd ali resident, BM

Role: CONTACT

01020111527

hanaa mohamed lecturer, MD

Role: CONTACT

01094608083

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hanaa M lecturer, MD

Role: primary

01094608083

References

Explore related publications, articles, or registry entries linked to this study.

Shan Z, Chen L, Lian X, Liu C, Shi B, Shi L, Tong N, Wang S, Weng J, Zhao J, Teng X, Yu X, Lai Y, Wang W, Li C, Mao J, Li Y, Fan C, Teng W. Iodine Status and Prevalence of Thyroid Disorders After Introduction of Mandatory Universal Salt Iodization for 16 Years in China: A Cross-Sectional Study in 10 Cities. Thyroid. 2016 Aug;26(8):1125-30. doi: 10.1089/thy.2015.0613. Epub 2016 Jul 22.

Reference Type RESULT
PMID: 27370068 (View on PubMed)

Mavromati M, Jornayvaz FR. Hypothyroidism-Associated Dyslipidemia: Potential Molecular Mechanisms Leading to NAFLD. Int J Mol Sci. 2021 Nov 26;22(23):12797. doi: 10.3390/ijms222312797.

Reference Type RESULT
PMID: 34884625 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://pubmed.ncbi.nlm.nih.gov/34104598/

Unraveling the Role of Hypothyroidism in Non-alcoholic Fatty Liver Disease Pathogenesis: Correlations, Conflicts, and the Current Stand

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

04-2025-201491

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Recurrent Pregnancy Loss and Thyroid Disease
NCT03106935 UNKNOWN EARLY_PHASE1