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

NCT ID: NCT01831869

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2022-04-30

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.

Conditions

Hypothyroidism; Thyroid Diseases; Endocrine System Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

L-thyroxine

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

Group Type: ACTIVE_COMPARATOR

L-thyroxine

Intervention Type: DRUG

blank

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

L-thyroxine

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ling Gao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiajun Zhao

Role: STUDY_CHAIR

Shandong Provincial Hospital

Locations

Shandong Provincial Hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

2012GSF11824

Identifier Type: -

Identifier Source: org_study_id