Clinical trial NCT01848171: Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism
Official title: Effects of Long-term L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Patients With Hypothyroidism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
Keywords: Hypothyroidism
Lipid
Atherosclerosis
Oxidative Stress
Chronic Inflammation
Endothelial Function
Adipocytokine
L-thyroxine
coronavirus disease 2019 (COVID-19)
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2013-05-07
Enrollment: 700
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Studies have shown that hypothyroidism increased the risk of COVID-19 composite poor outcomes. This study also aimed to investigate whether L-thyroxine replacement therapy was effective in reducing the incidence and mortality of COVID-19, and in improving the severity of COVID-19 and COVID-19 related complications.


Eligibility 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.

Primary outcomes:
measure: Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality
timeFrame: endpoint of the trail
Secondary outcomes:
measure: Change in Serum Lipid Levels
timeFrame: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed
measure: Change in Thickness of Blood Vessel Wall
timeFrame: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed
measure: Change in Oxidative Stress and Chronic Inflammatory Factors Associated with Atherosclerosis
timeFrame: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trail is completed
measure: Changes in Serum Metabolome and Lipidome
timeFrame: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trail is completed
Other outcomes:
measure: Rate of COVID-19, COVID-19 Mortality, COVID-19 Related Complications and Severity of COVID-19
timeFrame: Since January, 2023, every 6 months during the following follow-up period until the trail is completed
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
affiliation: Shandong Province Hospital
name: Zhao jiajun
role: STUDY_CHAIR
References:
citation: Yao Z, Zhao M, Gong Y, Chen W, Wang Q, Fu Y, Guo T, Zhao J, Gao L, Bo T. Relation of Gut Microbes and L-Thyroxine Through Altered Thyroxine Metabolism in Subclinical Hypothyroidism Subjects. Front Cell Infect Microbiol. 2020 Sep 18;10:495. doi: 10.3389/fcimb.2020.00495. eCollection 2020.
citation: Liu L, Yu Y, Zhao M, Zheng D, Zhang X, Guan Q, Xu C, Gao L, Zhao J, Zhang H. Benefits of Levothyroxine Replacement Therapy on Nonalcoholic Fatty Liver Disease in Subclinical Hypothyroidism Patients. Int J Endocrinol. 2017;2017:5753039. doi: 10.1155/2017/5753039. Epub 2017 Apr 4.