Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism

NCT01848171 | Unknown Phase 4 DMC

• 1 other identifier: 20130328
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality

  endpoint of the trail

Secondary Outcomes (4)

• Change in Serum Lipid Levels

  baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed

• Change in Thickness of Blood Vessel Wall

  baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed

• Change in Oxidative Stress and Chronic Inflammatory Factors Associated with Atherosclerosis

  baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trail is completed

• Changes in Serum Metabolome and Lipidome

  baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trail is completed

Other Outcomes (1)

• Rate of COVID-19, COVID-19 Mortality, COVID-19 Related Complications and Severity of COVID-19

  Since January, 2023, every 6 months during the following follow-up period until the trail is completed

Study Arms (2)

L-thyroxine

ACTIVE COMPARATOR

Oral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period

Drug: L-thyroxine

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NO INTERVENTION

No intervention

Interventions

L-thyroxine DRUG

Also known as: Euthyrox

L-thyroxine

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~75 years old
• Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

Related Publications (2)

• 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.

  PMID: 33072620 DERIVED

• 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.

  PMID: 28473851 DERIVED

MeSH Terms

Conditions

Hypothyroidism; Thyroid Diseases; Endocrine System Diseases; Atherosclerosis; COVID-19

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Zhao jiajun

  Shandong Province Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 7, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: January 18, 2023

Record last verified: 2022-05

Locations

CN (1)