Metabolomics of Thyroid Hormones

NCT ID: NCT03823859

Last Updated: 2022-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

332 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-12

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Central Hypothyroidism Hypothyroidism Hyperthyroidism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy volunteers

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

Indirect calorimetry

Intervention Type DIAGNOSTIC_TEST

Resting energy expenditure

Dual energy X-ray Absorptiometry (DXA)

Intervention Type DIAGNOSTIC_TEST

Body composition

Blood sampling

Intervention Type DIAGNOSTIC_TEST

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)

Indirect calorimetry

Intervention Type DIAGNOSTIC_TEST

Resting energy expenditure

Dual energy X-ray Absorptiometry (DXA)

Intervention Type DIAGNOSTIC_TEST

Body composition

Blood sampling

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Indirect calorimetry

Resting energy expenditure

Intervention Type DIAGNOSTIC_TEST

Dual energy X-ray Absorptiometry (DXA)

Body composition

Intervention Type DIAGNOSTIC_TEST

Blood sampling

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ETH Zurich

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthias Betz, PD Dr. med.

Role: STUDY_DIRECTOR

Klinik Endokrinologie, Diabetes und Metabolismus

Locations

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University Hospital Basel, Department of Endocrinology

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EKNZ 2018-01961

Identifier Type: -

Identifier Source: org_study_id

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