Metabolomics of Thyroid Hormones

University Hospital, Basel, Switzerland332 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

332

Conditions

Central Hypothyroidism Hypothyroidism Hyperthyroidism

Interventions

Indirect calorimetryDIAGNOSTIC_TEST

Resting energy expenditure

Dual energy X-ray Absorptiometry (DXA)DIAGNOSTIC_TEST

Body composition

Blood samplingDIAGNOSTIC_TEST

fT4, fT3, TSH, HDL, LDL, triglycerides, cholesterol, HbA1c, Glucose Thyroid panel

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Basel, Department of Endocrinology

Basel, Canton of Basel-City, Switzerland

Outcomes

Primary Outcomes

Metabolome signature of thyroid Hormone Status (MSTH)

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

Secondary Outcomes

Resting energy expenditure (REE)

Comparison of REE of healthy volunteers and Patients with thyroid dysfunction, measured by indirect calorimetry.

Time frame: baseline/single visit

Body composition concerning muscle mass

Comparison of muscle mass of healthy volunteers and patients with thyroid dysfunction, measured by DXA

Time frame: baseline/single visit

Body composition concerning fat mass

Comparison of fat mass of healthy volunteers and patients with thyroid dysfunction, measured by DXA

Time frame: baseline/single visit

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.