Overview

This trial is active, not recruiting.

Conditions hypothyroidism, thyroid diseases, endocrine system diseases
Treatment l-thyroxine
Phase phase 4
Sponsor Shandong Provincial Hospital
Start date July 2013
End date July 2023
Trial size 700 participants
Trial identifier NCT01848171, 20130328

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Oral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period
l-thyroxine Euthyrox
(No Intervention)
No intervention

Primary Outcomes

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

Secondary Outcomes

Measure
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
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
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

Male or female participants from 40 years up to 75 years old.

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.

Additional Information

Official title Effects of Long-term L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Patients With Hypothyroidism
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Shandong Provincial Hospital.