Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nasmi Niknam, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT02090907
First received: March 12, 2014
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Subclinical Hypothyroidism
Drug: Levothyroxine
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • Change from baseline flow-mediated dilation at 2 months [ Time Frame: At baseline and then 2 months after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: At baseline and then 2 months after treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: May 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levothyroxin
In the treatment group, daily doses of 100 mg of Levothyroxine will be administered every morning, half an hour before breakfast.
Drug: Levothyroxine
Placebo Comparator: 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.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02090907

Locations
Iran, Islamic Republic of
Khorshid endocrinology clinic
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Principal Investigator: Nasmi Niknam, M.D. Isfahan University of Medical Sciences
  More Information

Publications:
Responsible Party: Nasmi Niknam, Dr., Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02090907     History of Changes
Other Study ID Numbers: 392349
Study First Received: March 12, 2014
Last Updated: March 17, 2014
Health Authority: Iran: Ministry of Health

Keywords provided by Isfahan University of Medical Sciences:
Subclinical hypothyroidism
Atherosclerosis
Cardiovascular disease
Endothelial function
Prevention

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014