Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

Phase 2

Completed

• Conditions: Subclinical Hypothyroidism
• Interventions: Drug: Levothyroxine; Drug: Placebo

• Registration Number: NCT02090907
• Lead Sponsor: Isfahan University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-03
• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-17
• Last Update Submitted: 2014-03-17
• Study First Posted: 2014-03-18
• Last Update Posted: 2014-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levothyroxin	Levothyroxine	In the treatment group, daily doses of 100 mg of Levothyroxine will be administered every morning, half an hour before breakfast.
Placebo	Placebo	In the placebo group treatment regimen and advices are identical to that of the treatment group, except for using a pharmacologically neutral agent, with complete resemblance to the real treatment.

Primary Outcome Measures

Name	Time	Method
Change from baseline flow-mediated dilation at 2 months	At baseline and then 2 months after treatment	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.
Change from baseline intima-media thickness at 2 months	At baseline and then 2 months after treatment	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.

Trial Locations

Locations (1)

Khorshid endocrinology clinic; 🇮🇷 Isfahan, Iran, Islamic Republic of