University Hospital Basel, Department of Endocrinology
Basel, Canton of Basel-City, 4031, Switzerland
NCT Number: NCT03823859
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 cases where TSH cannot be reliably used.
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Notify Me18 year–80 year
All sexes
Observational
Basel, Canton of Basel-City, 4031, Switzerland
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 pituitary gland hormone thyrotropin (TSH). Patients with central hypothyroidism in whom pituitary insufficiency leads to hypothyroidism, TSH cannot be used to guide therapy. So far there are no reliable methods for therapy control in patients with central hypothyroidism.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All participants:
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
Resting energy expenditure
Body composition
fT4, fT3, TSH, HDL, LDL, triglycerides, cholesterol, HbA1c, Glucose Thyroid panel
Time frame: baseline/single visit
The MSTH will be tested against the current standard of diagnosis which is serum TSH level by multiple linear regression.
Time frame: baseline/single visit
Comparison of REE of healthy volunteers and Patients with thyroid dysfunction, measured by indirect calorimetry.
Time frame: baseline/single visit
Comparison of muscle mass of healthy volunteers and patients with thyroid dysfunction, measured by DXA
Time frame: baseline/single visit
Comparison of fat mass of healthy volunteers and patients with thyroid dysfunction, measured by DXA
University Hospital, Basel, Switzerland
Other
Acronym: MATcH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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