Metabolomics of Thyroid Hormones (MATcH)

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.

Study Overview

• Status: Completed
• Conditions: Hypothyroidism; Hyperthyroidism; Central Hypothyroidism
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 332

Contacts and Locations

Study Locations

• Switzerland
  • BS
    • Basel, BS, Switzerland, 4031
      • University Hospital Basel, Department of Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers will be recruited by means of advertisements (online or in the newspaper).

Patients will be recruited from the endocrinology outpatient clinics of the Department of Endocrinology, Diabetes and Metabolism, University Hospital Basel and patients referred from practicing endocrinologists.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline/single visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting energy expenditure (REE)	Comparison of REE of healthy volunteers and Patients with thyroid dysfunction, measured by indirect calorimetry.	baseline/single visit
Body composition concerning muscle mass	Comparison of muscle mass of healthy volunteers and patients with thyroid dysfunction, measured by DXA	baseline/single visit
Body composition concerning fat mass	Comparison of fat mass of healthy volunteers and patients with thyroid dysfunction, measured by DXA	baseline/single visit

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: ETH Zurich
• Investigators: Study Director: Matthias Betz, PD Dr. med., Klinik Endokrinologie, Diabetes und Metabolismus

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2018
• Primary Completion (Actual): July 28, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Hypothyroidism; Metabolomics; Thyroid Hormones; Hyperthyroidism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism; Hyperthyroidism
• Other Study ID Numbers: EKNZ 2018-01961

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No