Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism

This study is currently recruiting participants.
Verified July 2013 by Shandong Provincial Hospital
Sponsor:
Information provided by (Responsible Party):
Jia-jun Zhao, Shandong Provincial Hospital
ClinicalTrials.gov Identifier:
NCT01848171
First received: May 2, 2013
Last updated: July 19, 2013
Last verified: July 2013

May 2, 2013
July 19, 2013
July 2013
July 2023   (final data collection date for primary outcome measure)
Rate of First CVD Events, CVD Mortality and All-cause Mortality [ Time Frame: endpoint of the trail ] [ Designated as safety issue: No ]
  • Change in Serum Lipid Levels [ Time Frame: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed ] [ Designated as safety issue: No ]
  • Change in Thickness of Blood Vessel Wall [ Time Frame: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01848171 on ClinicalTrials.gov Archive Site
  • Change in Serum Lipid Levels [ Time Frame: baseline, 3 months, 6 months, every 12 months during the follpwing follow-up period until the trial is completed ] [ Designated as safety issue: No ]
  • Change in Thickness of Blood Vessel Wall [ Time Frame: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed ] [ Designated as safety issue: No ]
  • Change in Oxidative Stress and Chronic Inflammatory Factors Associated with Atherosclerosis [ Time Frame: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trail is completed ] [ Designated as safety issue: No ]
Not Provided
Not Provided
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Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism
Effects of Long-term L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Patients With Hypothyroid

Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is also reported increased risk for incidence of atherosclerosis and resulting coronary heart disease(CHD), heart failure(HF) and cardiovascular(CV) death. The effect of L-thyroxine replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid patients, especially in those with mild or moderate subclinical hypothyroidism. The present study was designed to investigate whether L-thyroxine replacement was effective in improving serum lipid profiles and retarding atherosclerosis progress.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypothyroidism
  • Thyroid Diseases
  • Endocrine System Diseases
Drug: L-thyroxine
Other Name: Euthyrox
  • Active Comparator: L-thyroxine
    Oral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period
    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.
 
Recruiting
700
July 2023
July 2023   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 40~75 years old
  • Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months

Exclusion Criteria:

  • Pregnant or lactating women
  • Severe hepatic or renal dysfunction
  • Psychiatric disabilities, acute cardiovascular and cerebrovascular diseases, chronic respiratory diseases, familiar hypercholesterolemia, malignancy, cholelithiasis, pancreatitis, bowel diseases and other disorders influencing lipid and bile acid metabolism
  • Taking lipid-lowering agents and other drugs influencing thyroid function, lipid and bile acid metabolism
  • Obviously poor compliance.
Both
40 Years to 75 Years
No
Contact: Gao Ling +8613793187189 gaoling1@medmail.com.cn
China
 
NCT01848171
20130328
Yes
Jia-jun Zhao, Shandong Provincial Hospital
Shandong Provincial Hospital
Not Provided
Study Chair: Zhao jiajun Shandong Province Hospital
Shandong Provincial Hospital
July 2013

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