Effects of N-acetylcysteine on Low T3 Syndrome
Information source: Federal University of Rio Grande do Sul
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myocardial Infarction; Euthyroid Sick Syndrome; Ischemic Heart Disease
Intervention: N-acetylcysteine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Federal University of Rio Grande do Sul Official(s) and/or principal investigator(s):
Josi Vidart, Principal Investigator, Affiliation: Federal University of Rio Grande do Sul
Ana maia, Study Director, Affiliation: Federal University of Rio Grande do Sul
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.
Clinical Details
Official title: Evaluation of the Effects of N-acetylcysteine on Thyroid Hormone Levels in the Low T3 Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Serum T3 Levels at 48 Hours
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul 90540001, Brazil
Instituto de Cardiologia, Porto Alegre, Rio Grande do Sul 90540001, Brazil
Additional Information
Programa de pós-graduação em endocrinologia Information on euthyroid sick syndrome
Related 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):1448-54. 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.
Starting date: November 2011
Last updated: March 30, 2015
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