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 April 2013
End date April 2022
Trial size 400 participants
Trial identifier NCT01831869, 2012GSF11824

Summary

Subclinical hypothyroidism (SCH) is a common condition affecting 3-10% of the general population, especially in women older than 50 years old. It is controversial whether SCH can lead to increased risks of cardiovascular (CV) disease and whether treatment with L-thyroxine reverses these risks. The present study was designed to evaluate the effect of L-thyroxine treatment in SCH on lipid profile, atherosclerosis, endothelial function, serum inflammatory factors and adipocytokines.

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, starting dose 25 or 50 micrograms once daily.
l-thyroxine
(No Intervention)
no intervention

Primary Outcomes

Measure
change in lipid profile
time frame: measured at baseline; 6 month; 12 months and 24 months.
change in thickness of blood vessel wall
time frame: measured at baseline; 6 months; 12 months and 24 months.

Secondary Outcomes

Measure
change in endothelial function
time frame: measured at baseline; 6 months; 12 months and 24 months.
change of adipocytokines
time frame: measured at baseline; 6 months; 12 months and 24 months.
Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis
time frame: measured at baseline; 6 months; 12 months and 24 months.

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - Male and female aged of 18 to 60 years old; - Diagnosis was subclinical hypothyroidism(elevated serum thyroid-stimulating hormone levels with normal serum free T4 levels measured at least two times with a three-month interval); - untreated. Exclusion Criteria: - Pregnancy or lactation women; - Presence of pituitary/hypothalamic disorders, diabetes mellitus or other endocrinal and metabolic disorders; - Presence of psychological or physical disabilities,acute infection, cerebrovascular or cardiovascular disease, chronic respiratory disease and other illnesses known to alter lipid metabolism; - Taking lipid-lowering agents and other drugs that known to influence thyroid function, blood pressure, heart function or bile acids; - Obviously poor compliance.

Additional Information

Official title The Beneficial Effect of L-Thyroxine Long -Term Replacement on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism: A Prospective Study
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Shandong Provincial Hospital.