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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


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: Effects of Long-term L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Patients With Hypothyroid

Resource links provided by NLM:


Further study details as provided by Shandong Provincial Hospital:

Primary Outcome Measures:
  • Rate of First CVD Events, CVD Mortality and All-cause Mortality [ Time Frame: endpoint of the trail ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 700
Study Start Date: July 2013
Estimated Study Completion Date: July 2023
Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: L-thyroxine
Oral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period
Drug: L-thyroxine
Other Name: Euthyrox
No Intervention: blank
No intervention

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01848171

Contacts
Contact: Gao Ling +8613793187189 gaoling1@medmail.com.cn

Locations
China, Shandong
Shandong Provincial Hospital Recruiting
Jinan, Shandong, China, 250021
Contact: Meng Zhao    86531-68776094    zjsylpzm@163.com   
Sponsors and Collaborators
Shandong Provincial Hospital
Investigators
Study Chair: Zhao jiajun Shandong Province Hospital
  More Information

No publications provided

Responsible Party: Jia-jun Zhao, Professor, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT01848171     History of Changes
Other Study ID Numbers: 20130328
Study First Received: May 2, 2013
Last Updated: July 19, 2013
Health Authority: China: Ethics Committee

Keywords provided by Shandong Provincial Hospital:
Hypothyroidism
Lipid
Atherosclerosis
Oxidative Stress
Chronic Inflammation
Endothelial Function
Adipocytokine
L-thyroxine

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

ClinicalTrials.gov processed this record on August 27, 2014