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Status unknownNCT01831869Updated Sep 12, 2018

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

A Phase 4 interventional study of L-thyroxine in Hypothyroidism, Thyroid Diseases and Endocrine System Diseases, sponsored by Shandong Provincial Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-09-12.

Sponsored by Shandong Provincial Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypothyroidism
  • Thyroid Diseases
  • Endocrine System Diseases

Keywords

  • Subclinical hypothyroidism
  • L-thyroxine
  • Lipid
  • endothelial function
  • inflammatory factor
  • adipocytokine
03

In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's planned enrollment of 400 is above the median of 106 across 882 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Shandong Provincial Hospital is the lead sponsor of 58 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Active comparator
    L-thyroxine

    Oral administration, starting dose 25 or 50 micrograms once daily.

    Drug: L-thyroxine

  • No intervention
    blank

    no intervention

Interventions

  • DrugL-thyroxine
06

What researchers measure

Primary outcomes

  1. change in lipid profile

    Time frame: measured at baseline; 6 month; 12 months and 24 months.

  2. change in thickness of blood vessel wall

    Time frame: measured at baseline; 6 months; 12 months and 24 months.

Secondary outcomes

  1. change in endothelial function

    Time frame: measured at baseline; 6 months; 12 months and 24 months.

  2. change of adipocytokines

    Time frame: measured at baseline; 6 months; 12 months and 24 months.

  3. Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis

    Time frame: measured at baseline; 6 months; 12 months and 24 months.

07

Study locations

1 site
  • Shandong Provincial Hospital
    Jinan, Shandong 250021, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01831869
Lead sponsor
Shandong Provincial Hospital
Responsible party
Ling Gao (Professor, Shandong Provincial Hospital) — Principal investigator
First posted
Apr 15, 2013
Start date
Apr 2013
Primary completion
Apr 2022 (estimated)
Completion
Apr 2022 (estimated)
Last update
Sep 12, 2018

Study contacts

Jiajun Zhao
study chair · Shandong Provincial Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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