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

Sponsor

Shandong Provincial Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01848171

Collaborator

(none)

700

Enrollment

Location

Arms

120

Duration (Months)

5.8

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality [endpoint of the trail]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.