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
Summary
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 LevelsChange in Thickness of Blood Vessel Wall Change in Oxidative Stress and Chronic Inflammatory Factors Associated with Atherosclerosis
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
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