Hypothyroidism | Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism
Hypothyroidism research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Endocrine System Diseases
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
L-thyroxineOral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period
Active, not recruiting
Start Date: July 2013
Completed Date: July 2023
Phase: Phase 4
Primary Outcome: Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality
Secondary Outcome: Change in Serum Lipid Levels
Study sponsors, principal investigator, and references
Principal Investigator: Zhao jiajun
Lead Sponsor: Shandong Provincial Hospital