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

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ClinicalTrials.gov Identifier: NCT01831869
Recruitment Status : Active, not recruiting
First Posted : April 15, 2013
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ling Gao, Shandong Provincial Hospital

April 7, 2013
April 15, 2013
September 12, 2018
April 2013
April 2022   (Final data collection date for primary outcome measure)
  • change in lipid profile [ Time Frame: measured at baseline; 6 month; 12 months and 24 months. ]
  • change in thickness of blood vessel wall [ Time Frame: measured at baseline; 6 months; 12 months and 24 months. ]
Same as current
Complete list of historical versions of study NCT01831869 on ClinicalTrials.gov Archive Site
  • change in endothelial function [ Time Frame: measured at baseline; 6 months; 12 months and 24 months. ]
  • change of adipocytokines [ Time Frame: measured at baseline; 6 months; 12 months and 24 months. ]
  • Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis [ Time Frame: measured at baseline; 6 months; 12 months and 24 months. ]
Same as current
Not Provided
Not Provided
 
Effect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism
The Beneficial Effect of L-Thyroxine Long -Term Replacement on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism: A Prospective Study
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hypothyroidism
  • Thyroid Diseases
  • Endocrine System Diseases
Drug: L-thyroxine
  • Active Comparator: L-thyroxine
    Oral administration, starting dose 25 or 50 micrograms once daily.
    Intervention: Drug: L-thyroxine
  • No Intervention: blank
    no intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
Same as current
April 2022
April 2022   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01831869
2012GSF11824
Yes
Not Provided
Not Provided
Ling Gao, Shandong Provincial Hospital
Shandong Provincial Hospital
Not Provided
Study Chair: Jiajun Zhao Shandong Provincial Hospital
Shandong Provincial Hospital
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP