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NCT Number: NCT07236697

Impact of Subclinical Hypothyroidism on Liver Enzymes and Lipid Profile

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liver enzymes

Diagnostic Test

subclinical hypothyroidism on liver enzymes and lipid profile

Primary outcomes

  1. Impact of Subclinical Hypothyroidism on Liver Enzymes and Lipid Profile

    Time frame: Baseline

    • Mean levels of liver enzymes (ALT, AST, GGT)
    • To determine whether there is a statistically significant difference in liver enzyme levels between individuals with subclinical hypothyroidism and euthyroid controls.
    • Mean values of lipid profile components (Total Cholesterol, LDL-C, HDL-C, Triglycerides) • To assess whether subclinical hypothyroidism is associated with dyslipidemia compared to the control group.

Study contacts

Contact information is provided by the study sponsor or research team.

hanaa mohamed lecturer, MD

CONTACT

[email protected]

01094608083

shahd ali resident, BM

CONTACT

[email protected]

01020111527

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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