Status:
COMPLETED
Metabolomics of Thyroid Hormones
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
ETH Zurich
Conditions:
Central Hypothyroidism
Hypothyroidism
Eligibility:
All Genders
18-80 years
Brief Summary
The aim of this study is to develop a metabolome signature of thyroid hormone status. The metabolome signature could be useful in diagnosis and treatment of thyroid dysfunction diseases, especially in...
Detailed Description
Primary Hypothyroidism is a frequent endocrine disorder, where the thyroid gland does not produce sufficient amounts of thyroid hormones. The substitution therapy is guided by measurement of the pitui...
Eligibility Criteria
Inclusion
- All participants:
- Age 18 to 80 years
- BMI 19 to 35 kg/m2
- Informed consent as documented by signature
- A) Patients with primary hyperthyroidism TSH \< 0.2 mIU/l and free thyroxine (fT4) \> 25 pM or fT3 \> 8 pM
- B) Patients with primary hypothyroidism, currently not sufficiently substituted TSH \> 8 milli-International unit (mIU)/l or fT4 \< 10 pM
- C) Patients with diagnosis of primary hypothyroidism, sufficiently substituted Documented diagnosis of primary hypothyroidism Substitution with L-Thyroxin TSH in target range between 0.5 and 2.5 mIU/l
- D) Patients with secondary hypothyroidism Pituitary disease with documented secondary hypothyroidism
Exclusion
- Diabetes mellitus (HbA1c \>6.5%)
- Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer
- Abuse of alcohol or illicit drugs
- Women who are pregnant or breast feeding
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
Key Trial Info
Start Date :
December 12 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT03823859
Start Date
December 12 2018
End Date
December 31 2021
Last Update
May 17 2022
Active Locations (1)
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1
University Hospital Basel, Department of Endocrinology
Basel, Canton of Basel-City, Switzerland, 4031