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

Primary Purpose

Hypothyroidism, Thyroid Diseases, Endocrine System Diseases

Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
L-thyroxine
Sponsored by
Shandong Provincial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothyroidism focused on measuring Hypothyroidism, Lipid, Atherosclerosis, Oxidative Stress, Chronic Inflammation, Endothelial Function, Adipocytokine, L-thyroxine, coronavirus disease 2019 (COVID-19)

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shandong Provincial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

L-thyroxine

blank

Arm Description

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

No intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Serum Lipid Levels
Change in Thickness of Blood Vessel Wall
Change in Oxidative Stress and Chronic Inflammatory Factors Associated with Atherosclerosis
Changes in Serum Metabolome and Lipidome

Full Information

First Posted
May 2, 2013
Last Updated
January 15, 2023
Sponsor
Shandong Provincial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01848171
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Provincial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism, Thyroid Diseases, Endocrine System Diseases
Keywords
Hypothyroidism, Lipid, Atherosclerosis, Oxidative Stress, Chronic Inflammation, Endothelial Function, Adipocytokine, L-thyroxine, coronavirus disease 2019 (COVID-19)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
L-thyroxine
Arm Type
Active Comparator
Arm Description
Oral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period
Arm Title
blank
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
L-thyroxine
Other Intervention Name(s)
Euthyrox
Primary Outcome Measure Information:
Title
Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality
Time Frame
endpoint of the trail
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao jiajun
Organizational Affiliation
Shandong Province Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33072620
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.
Results Reference
derived
PubMed Identifier
28473851
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.
Results Reference
derived

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

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