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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014