Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
332 participants
OBSERVATIONAL
2018-12-12
2021-12-31
Brief Summary
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Detailed Description
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The measurement of small endogenous metabolites might give investigators a metabolomics profile. This could help to discriminate between euthyroid, hypothyroid and hyperthyroid state and therefore could be used for diagnosis and therapy control of thyroid dysfunction diseases.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy volunteers
* Blood sampling (fT3, fT4, TSH, Lipids, Glucose, HbA1c)
* Indirect calorimetry
* Dual energy X-ray Absorptiometry (DXA)
Indirect calorimetry
Resting energy expenditure
Dual energy X-ray Absorptiometry (DXA)
Body composition
Blood sampling
fT4, fT3, TSH, HDL, LDL, triglycerides, cholesterol, HbA1c, Glucose Thyroid panel
Patients with thyroid dysfunction
Patients with Primary hypothyroidism newly diagnosed, Primary hypothyroidism substituted, hyperthyroidism, secondary hypothyroidism
* Blood sampling (fT3, fT4, TSH, Lipids, Glucose, HbA1c)
* Indirect calorimetry
* Dual energy X-ray Absorptiometry (DXA)
Indirect calorimetry
Resting energy expenditure
Dual energy X-ray Absorptiometry (DXA)
Body composition
Blood sampling
fT4, fT3, TSH, HDL, LDL, triglycerides, cholesterol, HbA1c, Glucose Thyroid panel
Interventions
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Indirect calorimetry
Resting energy expenditure
Dual energy X-ray Absorptiometry (DXA)
Body composition
Blood sampling
fT4, fT3, TSH, HDL, LDL, triglycerides, cholesterol, HbA1c, Glucose Thyroid panel
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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ETH Zurich
OTHER
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Matthias Betz, PD Dr. med.
Role: STUDY_DIRECTOR
Klinik Endokrinologie, Diabetes und Metabolismus
Locations
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University Hospital Basel, Department of Endocrinology
Basel, Canton of Basel-City, Switzerland
Countries
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Other Identifiers
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EKNZ 2018-01961
Identifier Type: -
Identifier Source: org_study_id
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