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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Jia-jun Zhao, Shandong Provincial Hospital

ClinicalTrials.gov Identifier:

NCT01848171

First received: May 2, 2013

Last updated: April 13, 2016

Last verified: April 2016

History of Changes

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 Hypothyroidism

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis Hypothyroidism

Drug Information available for: Levothyroxine Levothyroxine sodium

U.S. FDA Resources

Further study details as provided by 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 ] [ 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 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 ]
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 (Adult, Senior)
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

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 13, 2016
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 Hypothyroidism Endocrine System Diseases Thyroid Diseases	Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 28, 2016

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