MATcH: Metabolomics of Thyroid Hormones

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT03823859

Collaborator

ETH Zurich (Other)

332

Enrollment

Location

36.6

Actual Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Central Hypothyroidism Hypothyroidism Hyperthyroidism	Diagnostic Test: Indirect calorimetry Diagnostic Test: Dual energy X-ray Absorptiometry (DXA) Diagnostic Test: Blood sampling

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

332 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Metabolomics of Thyroid Hormones

Actual Study Start Date :

Dec 12, 2018

Actual Primary Completion Date :

Jul 28, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Healthy volunteers Blood sampling (fT3, fT4, TSH, Lipids, Glucose, HbA1c) Indirect calorimetry Dual energy X-ray Absorptiometry (DXA)	Diagnostic Test: Indirect calorimetry Resting energy expenditure Diagnostic Test: Dual energy X-ray Absorptiometry (DXA) Body composition Diagnostic Test: 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)	Diagnostic Test: Indirect calorimetry Resting energy expenditure Diagnostic Test: Dual energy X-ray Absorptiometry (DXA) Body composition Diagnostic Test: Blood sampling fT4, fT3, TSH, HDL, LDL, triglycerides, cholesterol, HbA1c, Glucose Thyroid panel

Arm

Intervention/Treatment

Healthy volunteers

Blood sampling (fT3, fT4, TSH, Lipids, Glucose, HbA1c) Indirect calorimetry Dual energy X-ray Absorptiometry (DXA)

Diagnostic Test: Indirect calorimetry

Resting energy expenditure

Diagnostic Test: Dual energy X-ray Absorptiometry (DXA)

Body composition

Diagnostic Test: 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)

Diagnostic Test: Indirect calorimetry

Resting energy expenditure

Diagnostic Test: Dual energy X-ray Absorptiometry (DXA)

Body composition

Diagnostic Test: Blood sampling

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All participants:

Age 18 to 80 years
BMI 19 to 35 kg/m2
Informed consent as documented by signature

Patients with primary hyperthyroidism TSH < 0.2 mIU/l and free thyroxine (fT4) > 25 pM or fT3 > 8 pM
Patients with primary hypothyroidism, currently not sufficiently substituted TSH > 8 milli-International unit (mIU)/l or fT4 < 10 pM
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
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