Subclinical HypothyroidismNCT07236697
Impact of Subclinical Hypothyroidism on Liver Enzymes and Lipid Profile
An observational study of Subclinical Hypothyroidism, run by Assiut University at 1 site in Egypt.
Trial summary
the goal of the randomized controlled observational study is to observe the effect of subclinical hypothyroidism on liver enzymes and lipid profile Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Subclinical Hypothyroidism
- What is being tested?
- liver enzymes
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: internal medicine department
Who may be able to join
- • Age ≥ 18 years
- For SCH group: Elevated TSH with normal FT4
- For control group: Normal TSH and FT4 levels
Who cannot join
- • Evident hypothyroidism or hyperthyroidism
- Diagnosed with diabetes mellitus
- Chronic liver disease
- Chronic kidney disease
- Use of lipid-lowering or thyroid medications
- Pregnancy
- Alcohol abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut university hospitals
Asyut
Hanaa M lecturer, MD, 01094608083, hanaaried@aun.edu.eg
About this study
the goal of the randomized controlled observational study is to observe the effect of subclinical hypothyroidism on liver enzymes and lipid profile
Read the detailed description
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
- Subclinical Hypothyroidism
- Being tested
- liver enzymes
- Keywords
- subclinical hypothyroidism on liver enzymes and lipid profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver enzymesDiagnostic test
subclinical hypothyroidism on liver enzymes and lipid profile
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Subclinical Hypothyroidism on Liver Enzymes and Lipid Profile
- 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subclinical HypothyroidismStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahd Ali Mohamed, Assiut University
- Investigators
- Muhammad Abbas Said, professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236697
- Sponsor's protocol ID
- 04-2025-201491
- Status last verified
- Sep 2025
- First submitted
- 15 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27370068Mavromati 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.
PubMed 34884625
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Subclinical Hypothyroidism on Liver Enzymes and Lipid Profile
- ClinicalTrials.gov ID
- NCT07236697
- Acronym / sponsor ID
- 04-2025-201491
- Conditions
- Subclinical Hypothyroidism
- Keywords
- subclinical hypothyroidism on liver enzymes and lipid profile
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the goal of the randomized controlled observational study is to observe the effect of subclinical hypothyroidism on liver enzymes and lipid profile
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- internal medicine department
Key inclusion criteria (3 listed)
- • Age ≥ 18 years
Key exclusion criteria (7 listed)
- • Evident hypothyroidism or hyperthyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver enzymessubclinical hypothyroidism on liver enzymes and lipid profile | Diagnostic test | – |
Primary outcome
Impact of Subclinical Hypothyroidism on Liver Enzymes and Lipid Profile
Time frame: Baseline
1. 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. 2. 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 27370068Shan 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.
- Results publication: PubMed 34884625Mavromati 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.
- Unraveling the Role of Hypothyroidism in Non-alcoholic Fatty Liver Disease Pathogenesis: Correlations, Conflicts, and the Current StandLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Subclinical Hypothyroidism
Not yet recruitingObservational study
Impact of Overt and Subclinical Hypothyroidism on Liver Fibrosis in Patients With MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-Alcoholic Fatty Liver Disease
Not yet recruitingObservational study
Subclinical Hypothyroidism and Disease Activity in Rheumatoid Arthritis
Rheumatoid Arthritis, Subclinical Hypothyroidism
Not yet recruitingObservational study
Hypothyroidism and Liver Fibrosis Severity in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease, Hypothyroidism
Not yet recruitingPhase 4
Discontinuation of Low-Dose Levothyroxine in Older Adults With Subclinical Hypothyroidism
Hypothyroidism
Recruiting
Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism
Levothyroxine, Cardiac Function
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhammad Abbas Said, professor principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subclinical Hypothyroidism, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shahd ali resident, BM (01020111527, sh.ja.me2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Subclinical Hypothyroidism on Liver Enzymes and Lipid Profile (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07236697, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.