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

Information source: Shandong Provincial Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypothyroidism; Thyroid Diseases; Endocrine System Diseases

Intervention: L-thyroxine (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Shandong Provincial Hospital

Official(s) and/or principal investigator(s):
Jiajun Zhao, Study Chair, Affiliation: Shandong Provincial Hospital


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

change in lipid profile

change in thickness of blood vessel wall

Secondary outcome:

change in endothelial function

change of adipocytokines

Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


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.

Locations and Contacts

Shandong Provincial Hospital, Jinan, Shandong 250021, China
Additional Information

Starting date: April 2013
Last updated: May 18, 2015

Page last updated: August 23, 2015

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