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

Sponsor

Shandong Provincial Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01831869

Collaborator

(none)

400

Enrollment

Location

Arms

108

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: L-thyroxine Oral administration, starting dose 25 or 50 micrograms once daily.	Drug: L-thyroxine
No Intervention: blank no intervention

Arm

Intervention/Treatment

Active Comparator: L-thyroxine

Oral administration, starting dose 25 or 50 micrograms once daily.

Drug: L-thyroxine

No Intervention: blank

no intervention

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

change in endothelial function [measured at baseline; 6 months; 12 months and 24 months.]
change of adipocytokines [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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.