Effect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism

Hypothyroidism Clinical Trial

Official title:

The Beneficial Effect of L-Thyroxine Long -Term Replacement on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism: A Prospective Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01831869
• Other study ID #: 2012GSF11824
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: April 2013
• Est. completion date: April 2022

Study information

• Verified date: September 2018
• Source: Shandong Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Endocrine System Diseases
• Hypothyroidism
• Thyroid Diseases

Intervention

Drug:
• L-thyroxine

Locations

Country	Name	City	State
China	Shandong Provincial Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in lipid profile		measured at baseline; 6 month; 12 months and 24 months.
Primary	change in thickness of blood vessel wall		measured at baseline; 6 months; 12 months and 24 months.
Secondary	change in endothelial function		measured at baseline; 6 months; 12 months and 24 months.
Secondary	change of adipocytokines		measured at baseline; 6 months; 12 months and 24 months.
Secondary	Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis		measured at baseline; 6 months; 12 months and 24 months.