Effect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism
Information source: Shandong Provincial Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypothyroidism; Thyroid Diseases; Endocrine System Diseases
Intervention: L-thyroxine (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Shandong Provincial Hospital Official(s) and/or principal investigator(s): Jiajun Zhao, Study Chair, Affiliation: Shandong Provincial Hospital
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.
Clinical Details
Official title: The Beneficial Effect of L-Thyroxine Long -Term Replacement on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism: A Prospective Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: change in lipid profilechange in thickness of blood vessel wall
Secondary outcome: change in endothelial functionchange of adipocytokines Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Shandong Provincial Hospital, Jinan, Shandong 250021, China
Additional Information
Starting date: April 2013
Last updated: May 18, 2015
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