Back to resultsEffect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism
Primary Purpose
Hypothyroidism, Thyroid Diseases, Endocrine System Diseases
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
L-thyroxine
Sponsored by
About this trial
This is an interventional treatment trial for Hypothyroidism focused on measuring Subclinical hypothyroidism, L-thyroxine, Lipid, endothelial function, inflammatory factor, adipocytokine
Eligibility 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.
Sites / Locations
- Shandong Provincial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
L-thyroxine
blank
Arm Description
Oral administration, starting dose 25 or 50 micrograms once daily.
no intervention
Outcomes
Primary Outcome Measures
change in lipid profile
change in thickness of blood vessel wall
Secondary Outcome Measures
change in endothelial function
change of adipocytokines
Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis
Full Information
NCT ID
NCT01831869
First Posted
April 7, 2013
Last Updated
September 11, 2018
Sponsor
Shandong Provincial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01831869
Brief Title
Effect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism
Official Title
The Beneficial Effect of L-Thyroxine Long -Term Replacement on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism: A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Provincial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism, Thyroid Diseases, Endocrine System Diseases
Keywords
Subclinical hypothyroidism, L-thyroxine, Lipid, endothelial function, inflammatory factor, adipocytokine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
L-thyroxine
Arm Type
Active Comparator
Arm Description
Oral administration, starting dose 25 or 50 micrograms once daily.
Arm Title
blank
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Drug
Intervention Name(s)
L-thyroxine
Primary Outcome Measure Information:
Title
change in lipid profile
Time Frame
measured at baseline; 6 month; 12 months and 24 months.
Title
change in thickness of blood vessel wall
Time Frame
measured at baseline; 6 months; 12 months and 24 months.
Secondary Outcome Measure Information:
Title
change in endothelial function
Time Frame
measured at baseline; 6 months; 12 months and 24 months.
Title
change of adipocytokines
Time Frame
measured at baseline; 6 months; 12 months and 24 months.
Title
Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis
Time Frame
measured at baseline; 6 months; 12 months and 24 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiajun Zhao
Organizational Affiliation
Shandong Provincial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism
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