NCT07236697

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

November 15, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

November 15, 2025

Last Update Submit

November 15, 2025

Conditions

Keywords

subclinical hypothyroidism on liver enzymes and lipid profile

Outcome Measures

Primary Outcomes (1)

  • Impact of Subclinical Hypothyroidism on Liver Enzymes and Lipid Profile

    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.

    Baseline

Interventions

liver enzymesDIAGNOSTIC_TEST

subclinical hypothyroidism on liver enzymes and lipid profile

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

internal medicine department

You may qualify if:

  • Age ≥ 18 years
  • For SCH group: Elevated TSH with normal FT4
  • For control group: Normal TSH and FT4 levels

You may not qualify if:

  • Evident hypothyroidism or hyperthyroidism
  • Diagnosed with diabetes mellitus
  • Chronic liver disease
  • Chronic kidney disease
  • Use of lipid-lowering or thyroid medications
  • Pregnancy
  • Alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospitals

Asyut, Egypt

Location

Related Publications (2)

  • 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.

  • 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.

Related Links

Study Officials

  • Muhammad Abbas Said, professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

shahd ali resident, BM

CONTACT

hanaa mohamed lecturer, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

November 15, 2025

First Posted

November 19, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 19, 2025

Record last verified: 2025-09

Locations