NCT03823859

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
332

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

2.6 years

First QC Date

January 28, 2019

Last Update Submit

May 16, 2022

Conditions

Central HypothyroidismHypothyroidismHyperthyroidism

Keywords

HypothyroidismMetabolomicsThyroid HormonesHyperthyroidism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Resting energy expenditure (REE)

    baseline/single visit

  • Body composition concerning muscle mass

    baseline/single visit

  • Body composition concerning fat mass

    baseline/single visit

Study Arms (2)

Healthy volunteers

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

Diagnostic Test: Indirect calorimetryDiagnostic Test: Dual energy X-ray Absorptiometry (DXA)Diagnostic Test: Blood sampling

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

Interventions

Indirect calorimetryDIAGNOSTIC_TEST

Resting energy expenditure

Healthy volunteersPatients with thyroid dysfunction
Dual energy X-ray Absorptiometry (DXA)DIAGNOSTIC_TEST

Body composition

Healthy volunteersPatients with thyroid dysfunction
Blood samplingDIAGNOSTIC_TEST

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

Healthy volunteersPatients with thyroid dysfunction

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Department of Endocrinology

Basel, Canton of Basel-City, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and plasma

MeSH Terms

Conditions

HypothyroidismHyperthyroidism

Interventions

Absorptiometry, PhotonBlood Specimen Collection

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesSpecimen HandlingClinical Laboratory TechniquesPuncturesSurgical Procedures, Operative

Study Officials

  • Matthias Betz, PD Dr. med.

    Klinik Endokrinologie, Diabetes und Metabolismus

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

January 31, 2019

Study Start

December 12, 2018

Primary Completion

July 28, 2021

Study Completion

December 31, 2021

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations

CH(1)