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Search / Trial NCT05015725

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

Hypothyroidism Reverse T3 Quality Of Life

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.

Locations

Budapest, , Hungary

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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