Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism
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 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|
- 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.
|Study Start Date:||May 2013|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
In the treatment group, daily doses of 100 mg of Levothyroxine will be administered every morning, half an hour before breakfast.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02090907
|Iran, Islamic Republic of|
|Khorshid endocrinology clinic|
|Isfahan, Iran, Islamic Republic of|
|Principal Investigator:||Nasmi Niknam, M.D.||Isfahan University of Medical Sciences|