Effects of N-acetylcysteine on Low T3 Syndrome

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ClinicalTrials.gov Identifier: NCT01501110

Recruitment Status : Completed

First Posted : December 29, 2011

Results First Posted : March 31, 2015

Last Update Posted : March 31, 2015

Sponsor:

Collaborators:

Hospital de Clinicas de Porto Alegre

Programa de pós-graduação em endocrinologia

Information provided by (Responsible Party):

Josi Vidart, Federal University of Rio Grande do Sul

Study Description

Brief Summary:

The propose of this study is to determine whether N-acetylcysteine is effective in reversing the changes in thyroid hormones seen in critical illness, known as the low T3 syndrome.

Condition or disease	Intervention/treatment	Phase
Acute Myocardial Infarction Euthyroid Sick Syndrome Ischemic Heart Disease	Drug: N-acetylcysteine	Phase 4

Detailed Description:

The low T3 syndrome or nonthyroidal illness is characterized by low levels of T3, normal or high normal levels of rT3, low or normal levels of T4 and inappropriately normal or low levels of TSH. These changes affect up to 75% of patients and have prognostic implications.

Interleukin-6 (IL6) seems to have a causative role in the pathogenesis of nonthyroidal illness. There is evidence that the reduction in serum T3 was inversely associated with serum IL-6, while the rT3 have a positive association. The mechanism of action of cytokines on the metabolism of thyroid hormones has not been determined and the potential role of cytokines on the deiodases has been the focus of research.

In a cell culture model study, IL-6 was able to suppress the conversion of T4 to T3 by deiodases type 1 and 2 and stimulate the inactivation of T3 by deiodase type 3, a situation similar to nonthyroidal illness. The use of N-acetylcysteine prevented this alterations, been consistent with the hypothesis that IL6 inhibits the function of the deiodases by increasing the oxygen reactive species and by consuming gluthathione or some gluthathione dependent cofactor.

Considering the absence of human studies evaluating the use of N-acetylcysteine in nonthyroidal illness, the aim of this study is to investigate whether NAC has in vivo effect on changes of thyroid hormones.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	83 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Evaluation of the Effects of N-acetylcysteine on Thyroid Hormone Levels in the Low T3 Syndrome
Study Start Date :	November 2011
Actual Primary Completion Date :	July 2013
Actual Study Completion Date :	November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Acetylcysteine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: n-acetylcysteine intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.	Drug: N-acetylcysteine in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours Other Names: NAC acetylcysteine
No Intervention: no intervention No intervention

Outcome Measures

Primary Outcome Measures :

Serum T3 Levels at 48 Hours [ Time Frame: 48 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosis of acute myocardial infarction with less than 12 hours of evolution
reperfusion therapy (primary angioplasty)

Exclusion Criteria:

Thyroid disease
Chronic renal disease with renal replacement therapy
hepatic insufficiency
immunosuppression

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501110

Locations

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Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90540001
Instituto de Cardiologia
Porto Alegre, Rio Grande do Sul, Brazil, 90540001

Sponsors and Collaborators

Federal University of Rio Grande do Sul

Hospital de Clinicas de Porto Alegre

Programa de pós-graduação em endocrinologia

Investigators

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Principal Investigator:	Josi Vidart	Federal University of Rio Grande do Sul
Study Director:	Ana maia	Federal University of Rio Grande do Sul

More Information

Additional Information:

Information on euthyroid sick syndrome This link exits the ClinicalTrials.gov site

Publications:

Wajner SM, Goemann IM, Bueno AL, Larsen PR, Maia AL. IL-6 promotes nonthyroidal illness syndrome by blocking thyroxine activation while promoting thyroid hormone inactivation in human cells. J Clin Invest. 2011 May;121(5):1834-45. doi: 10.1172/JCI44678. Epub 2011 Apr 11.

Boelen A, Kwakkel J, Fliers E. Beyond low plasma T3: local thyroid hormone metabolism during inflammation and infection. Endocr Rev. 2011 Oct;32(5):670-93. doi: 10.1210/er.2011-0007. Epub 2011 Jul 26. Review.

Maia AL, Goemann IM, Meyer EL, Wajner SM. Deiodinases: the balance of thyroid hormone: type 1 iodothyronine deiodinase in human physiology and disease. J Endocrinol. 2011 Jun;209(3):283-97. doi: 10.1530/JOE-10-0481. Epub 2011 Mar 17. Review.

Bello G, Pennisi MA, Montini L, Silva S, Maviglia R, Cavallaro F, Bianchi A, De Marinis L, Antonelli M. Nonthyroidal illness syndrome and prolonged mechanical ventilation in patients admitted to the ICU. Chest. 2009 Jun;135(6):1448-1454. doi: 10.1378/chest.08-1816. Epub 2009 Mar 2.

Koenig RJ. Modeling the nonthyroidal illness syndrome. Curr Opin Endocrinol Diabetes Obes. 2008 Oct;15(5):466-9. doi: 10.1097/MED.0b013e32830eb838. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vidart J, Wajner SM, Leite RS, Manica A, Schaan BD, Larsen PR, Maia AL. N-acetylcysteine administration prevents nonthyroidal illness syndrome in patients with acute myocardial infarction: a randomized clinical trial. J Clin Endocrinol Metab. 2014 Dec;99(12):4537-45. doi: 10.1210/jc.2014-2192.

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Responsible Party:	Josi Vidart, Principal Investigator, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:	NCT01501110
Other Study ID Numbers:	110061
First Posted:	December 29, 2011 Key Record Dates
Results First Posted:	March 31, 2015
Last Update Posted:	March 31, 2015
Last Verified:	March 2015

Keywords provided by Josi Vidart, Federal University of Rio Grande do Sul:


Euthyroid Sick Syndrome low T3 syndrome deiodases oxidative stress ischemic heart disease

Additional relevant MeSH terms:

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Myocardial Infarction Heart Diseases Myocardial Ischemia Coronary Artery Disease Euthyroid Sick Syndromes Syndrome Infarction Disease Pathologic Processes Ischemia Necrosis Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis	Arterial Occlusive Diseases Thyroid Diseases Endocrine System Diseases Acetylcysteine N-monoacetylcystine Antiviral Agents Anti-Infective Agents Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes

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