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

This study is currently recruiting participants.
Verified December 2013 by Shandong Provincial Hospital
Sponsor:
Information provided by (Responsible Party):
Ling Gao, Shandong Provincial Hospital
ClinicalTrials.gov Identifier:
NCT01831869
First received: April 7, 2013
Last updated: December 1, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
Drug: L-thyroxine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Shandong Provincial Hospital:

Primary Outcome Measures:
  • change in lipid profile [ Time Frame: measured at baseline; 6 month; 12 months and 24 months. ] [ Designated as safety issue: No ]
  • change in thickness of blood vessel wall [ Time Frame: measured at baseline; 6 months; 12 months and 24 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in endothelial function [ Time Frame: measured at baseline; 6 months; 12 months and 24 months. ] [ Designated as safety issue: No ]
  • change of adipocytokines [ Time Frame: measured at baseline; 6 months; 12 months and 24 months. ] [ Designated as safety issue: No ]
  • Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis [ Time Frame: measured at baseline; 6 months; 12 months and 24 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: L-thyroxine
Oral administration, starting dose 25 or 50 micrograms once daily.
Drug: L-thyroxine
No Intervention: blank
no intervention

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01831869

Contacts
Contact: Ling Gao +86 53168776910 gaoling1@medmail.com.cn

Locations
China, Shandong
Shandong Provincial Hospital Recruiting
Jinan, Shandong, China, 250021
Contact: Shanshan Shao    86-531-68776094    shaoshanshan11@126.com   
Sponsors and Collaborators
Shandong Provincial Hospital
Investigators
Study Chair: Jiajun Zhao Shandong Provincial Hospital
  More Information

No publications provided

Responsible Party: Ling Gao, Professor, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT01831869     History of Changes
Other Study ID Numbers: 2012GSF11824
Study First Received: April 7, 2013
Last Updated: December 1, 2013
Health Authority: China: Ethics Committee

Keywords provided by Shandong Provincial Hospital:
Subclinical hypothyroidism
L-thyroxine
Lipid
endothelial function
inflammatory factor
adipocytokine

Additional relevant MeSH terms:
Atherosclerosis
Endocrine System Diseases
Hypothyroidism
Thyroid Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014