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Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism
This study is ongoing, but not recruiting participants.
Sponsor:
Shandong Provincial Hospital
Information provided by (Responsible Party):
Jia-jun Zhao, Shandong Provincial Hospital
ClinicalTrials.gov Identifier:
NCT01848171
First received: May 2, 2013
Last updated: April 25, 2017
Last verified: April 2017
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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 Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | Effects of Long-term L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Patients With Hypothyroidism |
Resource links provided by NLM:
Further study details as provided by Jia-jun Zhao, Shandong Provincial Hospital:
Primary Outcome Measures:
- Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality [ Time Frame: endpoint of the trail ]
Secondary Outcome Measures:
- 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 ]
- 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 ]
- 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 ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01848171
Please refer to this study by its ClinicalTrials.gov identifier: NCT01848171
Locations
| China, Shandong | |
| Shandong Provincial Hospital | |
| Jinan, Shandong, China, 250021 | |
Sponsors and Collaborators
Shandong Provincial Hospital
Investigators
| Study Chair: | Zhao jiajun | Shandong Province Hospital |
More Information
| 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: | April 25, 2017 |
Keywords provided by Jia-jun Zhao, Shandong Provincial Hospital:
|
Hypothyroidism Lipid Atherosclerosis Oxidative Stress |
Chronic Inflammation Endothelial Function Adipocytokine L-thyroxine |
Additional relevant MeSH terms:
|
Atherosclerosis Hypothyroidism Thyroid Diseases Endocrine System Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on July 19, 2017