Metabolomics of Thyroid Hormones

Hypothyroidism Clinical Trial

— MATcH  

Official title:

Metabolomics of Thyroid Hormones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823859
• Other study ID #: EKNZ 2018-01961
• Status: Completed
• Start date: December 12, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: December 31, 2021
• Est. primary completion date: July 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Hypothyroidism
• Hyperthyroidism
• Hypothyroidism

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Department of Endocrinology	Basel	BS

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	ETH Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

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