Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

Subclinical Hypothyroidism Clinical Trial

Official title:

Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02090907
• Other study ID #: 392349
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 12, 2014
• Last updated: March 17, 2014
• Start date: May 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothyroidism
• Subclinical Hypothyroidism

Intervention

Drug:
• Levothyroxine

• Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Khorshid endocrinology clinic	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (2)

Alibaz Oner F, Yurdakul S, Oner E, Kubat Uzum A, Erguney M. Evaluation of the effect of L-thyroxin therapy on endothelial functions in patients with subclinical hypothyroidism. Endocrine. 2011 Oct;40(2):280-4. doi: 10.1007/s12020-011-9465-2. Epub 2011 Apr 20. — View Citation

Walsh JP, Bremner AP, Bulsara MK, O'Leary P, Leedman PJ, Feddema P, Michelangeli V. Subclinical thyroid dysfunction as a risk factor for cardiovascular disease. Arch Intern Med. 2005 Nov 28;165(21):2467-72. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline and then 2 months after treatment	No
Primary	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.	At baseline and then 2 months after treatment	No