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

January 15, 2023 updated by: Jia-jun Zhao, Shandong Provincial Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

700

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: L-thyroxine
Oral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period
Drug: L-thyroxine
Other Names:
  • Euthyrox
No Intervention: blank
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality
Time Frame: endpoint of the trail
endpoint of the trail

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Serum Lipid Levels
Time Frame: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed
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
Time Frame: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed
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
Time Frame: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trail is completed
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
Time Frame: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trail is completed
baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trail is completed

Other Outcome Measures

Outcome Measure
Time Frame
Rate of COVID-19, COVID-19 Mortality, COVID-19 Related Complications and Severity of COVID-19
Time Frame: Since January, 2023, every 6 months during the following follow-up period until the trail is completed
Since January, 2023, every 6 months during the following follow-up period until the trail is completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Provincial Hospital

Investigators

  • Study Chair: Zhao jiajun, Shandong Province Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

May 2, 2013

First Posted (Estimate)

May 7, 2013

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 15, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130328

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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