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Effect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism

S

Shandong First Medical University

Status and phase

Unknown
Phase 4

Conditions

Thyroid Diseases
Hypothyroidism
Endocrine System Diseases

Treatments

Drug: L-thyroxine

Study type

Interventional

Funder types

Other

Identifiers

NCT01831869
2012GSF11824

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

400 participants in 2 patient groups

L-thyroxine
Active Comparator group
Description:
Oral administration, starting dose 25 or 50 micrograms once daily.
Treatment:
Drug: L-thyroxine
blank
No Intervention group
Description:
no intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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