Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

Phase 3CompletedNCT02090907

Isfahan University of Medical Sciences50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Subclinical Hypothyroidism

Interventions

Levothyroxine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline flow-mediated dilation at 2 months

Flow-mediated dilation will be assessed using standard method with a radiologist unaware to the study arms at baseline and then 2 months after treatment.

Time frame: At baseline and then 2 months after treatment

Change from baseline intima-media thickness at 2 months

Intima-media thickness will be assessed using standard method with a radiologist unaware to the study arms at baseline and then 2 months after treatment.