Central Hypothyroidism, Hypothyroidism, Hyperthyroidism
Conditions
Keywords
Hypothyroidism, Metabolomics, Thyroid Hormones, Hyperthyroidism
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 cases where TSH cannot be reliably used.
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 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.
Interventions
DIAGNOSTIC_TESTIndirect calorimetry
Resting energy expenditure
DIAGNOSTIC_TESTDual energy X-ray Absorptiometry (DXA)
Body composition
DIAGNOSTIC_TESTBlood sampling
fT4, fT3, TSH, HDL, LDL, triglycerides, cholesterol, HbA1c, Glucose Thyroid panel
Sponsors
ETH Zurich
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolome signature of thyroid Hormone Status (MSTH) | baseline/single visit | The MSTH will be tested against the current standard of diagnosis which is serum TSH level by multiple linear regression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting energy expenditure (REE) | baseline/single visit | Comparison of REE of healthy volunteers and Patients with thyroid dysfunction, measured by indirect calorimetry. |
| Body composition concerning muscle mass | baseline/single visit | Comparison of muscle mass of healthy volunteers and patients with thyroid dysfunction, measured by DXA |
| Body composition concerning fat mass | baseline/single visit | Comparison of fat mass of healthy volunteers and patients with thyroid dysfunction, measured by DXA |
Countries
Switzerland
Outcome results
None listed