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Completed

NCT Number: NCT03823859

Metabolomics of Thyroid Hormones

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Department of Endocrinology

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

indirect calorimetry

Diagnostic Test

Resting energy expenditure

Dual energy X-ray Absorptiometry (DXA)

Diagnostic Test

Body composition

Blood sampling

Diagnostic Test

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

Primary outcomes

  1. Metabolome signature of thyroid Hormone Status (MSTH)

    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.

Secondary outcomes

  1. Resting energy expenditure (REE)

    Time frame: baseline/single visit

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

  2. Body composition concerning muscle mass

    Time frame: baseline/single visit

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

  3. Body composition concerning fat mass

    Time frame: baseline/single visit

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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • ETH Zurich

Registry information

Acronym: MATcH

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2019
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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