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

Phase 4

• Conditions: Hypothyroidism; Thyroid Diseases; Endocrine System Diseases
• Interventions: Drug: L-thyroxine

• Registration Number: NCT01831869
• Lead Sponsor: Shandong Provincial Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-07
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-15
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-11
• Last Update Posted: 2018-09-12
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-thyroxine	L-thyroxine	Oral administration, starting dose 25 or 50 micrograms once daily.

Primary Outcome Measures

Name	Time	Method
change in thickness of blood vessel wall	measured at baseline; 6 months; 12 months and 24 months.
change in lipid profile	measured at baseline; 6 month; 12 months and 24 months.

Secondary Outcome Measures

Name	Time	Method
change of adipocytokines	measured at baseline; 6 months; 12 months and 24 months.
change in endothelial function	measured at baseline; 6 months; 12 months and 24 months.
Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis	measured at baseline; 6 months; 12 months and 24 months.

Trial Locations

Locations (1)

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China