Effect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism

The Beneficial Effect of L-Thyroxine Long -Term Replacement on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism: A Prospective Study

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01831869

Enrollment

400

Registered

2013-04-15

Start date

2013-04-30

Completion date

2022-04-30

Last updated

2018-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endocrine System Diseases, Hypothyroidism, Thyroid Diseases

Keywords

Subclinical hypothyroidism, L-thyroxine, Lipid, endothelial function, inflammatory factor, adipocytokine

Brief summary

Subclinical hypothyroidism (SCH) is a common condition affecting 3-10% of the general population, especially in women older than 50 years old. It is controversial whether SCH can lead to increased risks of cardiovascular (CV) disease and whether treatment with L-thyroxine reverses these risks. The present study was designed to evaluate the effect of L-thyroxine treatment in SCH on lipid profile, atherosclerosis, endothelial function, serum inflammatory factors and adipocytokines.

Interventions

DRUGL-thyroxine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Male and female aged of 18 to 60 years old; * Diagnosis was subclinical hypothyroidism(elevated serum thyroid-stimulating hormone levels with normal serum free T4 levels measured at least two times with a three-month interval); * untreated.

Exclusion criteria

* Pregnancy or lactation women; * Presence of pituitary/hypothalamic disorders, diabetes mellitus or other endocrinal and metabolic disorders; * Presence of psychological or physical disabilities,acute infection, cerebrovascular or cardiovascular disease, chronic respiratory disease and other illnesses known to alter lipid metabolism; * Taking lipid-lowering agents and other drugs that known to influence thyroid function, blood pressure, heart function or bile acids; * Obviously poor compliance.

Design outcomes

Primary

Measure	Time frame
change in lipid profile	measured at baseline; 6 month; 12 months and 24 months.
change in thickness of blood vessel wall	measured at baseline; 6 months; 12 months and 24 months.

Secondary

Measure	Time frame
change in endothelial function	measured at baseline; 6 months; 12 months and 24 months.
change of adipocytokines	measured at baseline; 6 months; 12 months and 24 months.
Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis	measured at baseline; 6 months; 12 months and 24 months.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026