- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01501110
Effects of N-acetylcysteine on Low T3 Syndrome
Evaluation of the Effects of N-acetylcysteine on Thyroid Hormone Levels in the Low T3 Syndrome
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90540001
- Hospital de Clínicas de Porto Alegre
-
Porto Alegre, Rio Grande do Sul, Brazil, 90540001
- Instituto de Cardiología
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: n-acetylcysteine
intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.
|
in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours
Other Names:
|
No Intervention: no intervention
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum T3 Levels at 48 Hours
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Josi Vidart, Federal University of Rio Grande do Sul
- Study Director: Ana maia, Federal University of Rio Grande do Sul
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Endocrine System Diseases
- Disease
- Thyroid Diseases
- Coronary Disease
- Myocardial Infarction
- Infarction
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Syndrome
- Euthyroid Sick Syndromes
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
- 110061
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ischemic Heart Disease
-
Genzyme, a Sanofi CompanyTerminatedIschemic Heart Disease | Ischemic Cardiomyopathy | Ischemic Heart FailureBelgium, France, Germany, Italy, Switzerland, United Kingdom
-
Cardiocentro TicinoTerminatedChronic Ischemic Heart DiseaseSwitzerland
-
University of AlbertaRecruitingCoronary Artery Disease | Stable Ischemic Heart Disease | Beta-blocker TherapyCanada
-
Gerencia de Atención Primaria, MadridServicio Canario de Salud; Avedis Donabedian Research InstituteCompletedIschemic Heart Disease ChronicSpain
-
Michael SekelaCompletedChronic Ischemic Heart DiseaseUnited States
-
University of PecsCompleted
-
Rigshospitalet, DenmarkNot yet recruitingChronic Ischemic Heart DiseaseDenmark
-
The University of Texas Health Science Center,...National Heart, Lung, and Blood Institute (NHLBI); Cardiovascular Cell Therapy...CompletedIschemic Cardiomyopathy | Left Ventricular Dysfunction | Angina | Chronic Ischemic Heart DiseaseUnited States
-
Affiliated Hospital to Academy of Military Medical...Ivy Institute of Stem Cells Co. LtdUnknownHeart Failure | Angina | Chronic Ischemic Heart DiseaseChina
-
University of EdinburghUnknown
Clinical Trials on N-acetylcysteine
-
Medical University of South CarolinaCompleted
-
Institut d'Anesthesiologie des Alpes MaritimesCompleted
-
Rajavithi HospitalCompletedChemotherapy-induced Peripheral NeuropathyThailand
-
University of Sao Paulo General HospitalActive, not recruiting
-
Indiana UniversityBioAdvantex PharmaCompletedHIV | Endothelial Dysfunction | Oxidative StressUnited States
-
Assaf-Harofeh Medical CenterUnknownChronic Kidney Diseases | General AnesthesiaIsrael
-
Assistance Publique - Hôpitaux de ParisTerminatedSelenoprotein N-related MyopathyFrance
-
VA Office of Research and DevelopmentNational Center for Complementary and Integrative Health (NCCIH)CompletedDiabetic Nephropathy | Proteinuria | Oxidative StressUnited States
-
University of ChicagoNational Institute on Drug Abuse (NIDA); University of MinnesotaCompletedTobacco Use Disorder | GamblingUnited States
-
Universidade Estadual de LondrinaUnknownInflammation | Tobacco Smoking | Oxidative StressBrazil