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Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02090907
Enrollment
50
Registered
2014-03-18
Start date
2013-05-31
Completion date
2014-02-28
Last updated
2014-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subclinical Hypothyroidism

Keywords

Subclinical hypothyroidism, Atherosclerosis, Cardiovascular disease, Endothelial function, Prevention

Brief summary

Hypothyroidism is risk factor in atherosclerotic cardiovascular diseases, but there is a controversy in effect of subclinical hypothyroidism on cardiovascular diseases. We aim to estimate the relation between subclinical hypothyroidism and endothelial dysfunction and the effects of levothyroxine therapy on it. Patients with confirmed subclinical hypothyroidism by lab results will be randomized to two groups of treatment with one daily dose of 100 mg Levothyroxine or placebo. The flow-mediated dilation and intima media thickness are evaluated before and after the study.

Interventions

DRUGLevothyroxine
DRUGPlacebo

Sponsors

Isfahan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* age 18 to 65 * confirmed subclinical hypothyroidism

Exclusion criteria

* receiving of other treatments for hypothyroidism * patients with other major medical disorders * smoking * hyperlipidemia * obesity

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline flow-mediated dilation at 2 monthsAt baseline and then 2 months after treatmentFlow-mediated dilation will be assessed using standard method with a radiologist unaware to the study arms at baseline and then 2 months after treatment.
Change from baseline intima-media thickness at 2 monthsAt baseline and then 2 months after treatmentIntima-media thickness will be assessed using standard method with a radiologist unaware to the study arms at baseline and then 2 months after treatment.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026