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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

Tracking Information
First Submitted Date  ICMJE April 7, 2013
First Posted Date  ICMJE April 15, 2013
Last Update Posted Date September 12, 2018
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2013)
  • 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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2013)
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism
Official Title  ICMJE The Beneficial Effect of L-Thyroxine Long -Term Replacement on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism: A Prospective Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypothyroidism
  • Thyroid Diseases
  • Endocrine System Diseases
Intervention  ICMJE Drug: L-thyroxine
Study Arms  ICMJE
  • Active Comparator: L-thyroxine
    Oral administration, starting dose 25 or 50 micrograms once daily.
    Intervention: Drug: L-thyroxine
  • No Intervention: blank
    no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2013)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01831869
Other Study ID Numbers  ICMJE 2012GSF11824
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ling Gao, Shandong Provincial Hospital
Study Sponsor  ICMJE Shandong Provincial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jiajun Zhao Shandong Provincial Hospital
PRS Account Shandong Provincial Hospital
Verification Date September 2018

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