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Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

Information source: Isfahan University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Subclinical Hypothyroidism

Intervention: Levothyroxine (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Isfahan University of Medical Sciences

Official(s) and/or principal investigator(s):
Nasmi Niknam, M.D., Principal Investigator, Affiliation: Isfahan University of Medical Sciences

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.

Clinical Details

Official title: Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

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

Primary outcome:

Change from baseline flow-mediated dilation at 2 months

Change from baseline intima-media thickness at 2 months

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Khorshid endocrinology clinic, Isfahan, Iran, Islamic Republic of
Additional Information

Related publications:

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.

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.

Starting date: May 2013
Last updated: March 17, 2014

Page last updated: August 23, 2015

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