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Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in 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):
Zhao jiajun, Study Chair, Affiliation: Shandong Province Hospital


Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is also reported increased risk for incidence of atherosclerosis and resulting coronary heart disease(CHD), heart failure(HF) and cardiovascular(CV) death. The effect of L-thyroxine replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid patients, especially in those with mild or moderate subclinical hypothyroidism. The present study was designed to investigate whether L-thyroxine replacement was effective in improving serum lipid profiles and retarding atherosclerosis progress.

Clinical Details

Official title: Effects of Long-term L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Patients With Hypothyroidism

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

Primary outcome: Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality

Secondary outcome:

Change in Serum Lipid Levels

Change in Thickness of Blood Vessel Wall

Change in Oxidative Stress and Chronic Inflammatory Factors Associated with Atherosclerosis


Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- 40~75 years old

- Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum

interval period of three months Exclusion Criteria:

- Pregnant or lactating women

- Severe hepatic or renal dysfunction

- Psychiatric disabilities, acute cardiovascular and cerebrovascular diseases, chronic

respiratory diseases, familiar hypercholesterolemia, malignancy, cholelithiasis, pancreatitis, bowel diseases and other disorders influencing lipid and bile acid metabolism

- Taking lipid-lowering agents and other drugs influencing thyroid function, lipid and

bile acid metabolism

- Obviously poor compliance.

Locations and Contacts

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

Starting date: July 2013
Last updated: November 19, 2014

Page last updated: August 23, 2015

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