The Relationship Between Serum rT3 Concentrations, T3/T4 Ratio, and Symptoms/Quality of Life in Treated Hypothyroid Patients
Launched by SEMMELWEIS UNIVERSITY · Aug 16, 2021
Trial Information
Current as of June 04, 2025
Completed
Keywords
ClinConnect Summary
Rationale: L-thyroxin (T4) substitution is the mainstay of treatment for hypothyroidism irrespective of disease origin. In a subset of patients with hypothyroidism however an inadequate peripheral T4-\>T3 conversion is hypostasized by some authors. This is speculated to lead to tissue level hypothyroidism and persistent symptoms even with adequate T4 replacement. As a potential pathogenetic mechanism, the inborn or acquired defect of peripheral deiodinases, decreased T3 and increased rT3 production is suggested.
Few results support this hypothesis. A decreased T3/T4 ratio has been reported...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • At least 18 years of age, inclusive, at the time of signing informed consent form.
- • Hypothyroidism treated for \>2 years
- • TSH stable between 0.4 and 4.0 mIU/L for the past 6 months (at least 2 measurements)
- Exclusion Criteria:
- • Abnormal TSH on screening
- • Unwilling or unable to participate/sign informed consent
- • Changes in thyroxine dose or any other medication in the previous month
- • Severe obesity (BMI \[body mass index\] \>35kg/m2)
- * Other significant comorbidity:
- • History of ischaemic heart disease, valvular defect, stent placement, heart failure, stroke or TIA (transient ischemic attack)
- • Diabetes mellitus under OAD (oral antidiabetic drug) or insulin treatment
- • eGFR (estimated glomerular filtration rate) \<60ml/min at screening, calculated by EPI formula
- • History of liver disease, AST/ALT\>3 times normal or GGT (gamma-glutamil transferase) \>2 times normal or hyperbilirubinaemia at screening
- • Systemic autoimmune condition currently under treatment (RA \[rheumatoid arthritis\], lupus, systemic sclerosis etc.)
- • Active malignancy
About Semmelweis University
Semmelweis University, located in Budapest, Hungary, is a prestigious institution renowned for its commitment to advancing medical education, research, and healthcare innovation. As a prominent clinical trial sponsor, the university leverages its extensive expertise in various medical fields to conduct rigorous clinical studies aimed at improving patient outcomes and enhancing therapeutic strategies. With a focus on ethical standards and scientific excellence, Semmelweis University collaborates with a network of healthcare professionals and researchers to translate groundbreaking discoveries into practical applications, ultimately contributing to the global advancement of medical science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Budapest, , Hungary
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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