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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01848171
Recruitment Status : Active, not recruiting
First Posted : May 7, 2013
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Jia-jun Zhao, Shandong Provincial Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypothyroidism Thyroid Diseases Endocrine System Diseases Drug: L-thyroxine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Long-term L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Patients With Hypothyroidism
Study Start Date : July 2013
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

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Arms and Interventions
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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 Name: Euthyrox
No Intervention: blank
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality [ Time Frame: endpoint of the trail ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848171


Locations
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China, Shandong
Shandong Provincial Hospital
Jinan, Shandong, China, 250021
Sponsors and Collaborators
Shandong Provincial Hospital
Investigators
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Study Chair: Zhao jiajun Shandong Province Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jia-jun Zhao, Professor, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT01848171    
Other Study ID Numbers: 20130328
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Keywords provided by Jia-jun Zhao, Shandong Provincial Hospital:
Hypothyroidism
Lipid
Atherosclerosis
Oxidative Stress
 Chronic Inflammation
Endothelial Function
Adipocytokine
L-thyroxine
Additional relevant MeSH terms:
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Atherosclerosis
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases