NCT03949361

Brief Summary

The aim of the study is to investigate whether treatment with glucocorticoids leads to a change in heat production of the human body at mild cold conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

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

First Submitted

Initial submission to the registry

April 2, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

2.5 years

First QC Date

April 2, 2019

Last Update Submit

January 24, 2022

Conditions

Thermoregulation Impairment

Keywords

GlucocorticoidsBrown Adipose tissueCold Induced ThermogenesisResting Metabolic Rate

Outcome Measures

Primary Outcomes (1)

  • Cold-induced thermogenesis (CIT) under glucocorticoids

    Comparison of CIT change off-glucocorticoids with warm ischemia time (WIT) on-glucocorticoids by using indirect calorimetry. Comparing two Groups (Observation group A and B) we will address the CIT change from glucocorticoid start to 4-8 weeks into treatment (group A) and the CIT change from glucocorticoid therapy to weaning off upon more than 3 months after glucocorticoid withdrawal (group B)

    Change from glucocortoid start to +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)

Secondary Outcomes (4)

  • Resting metabolic rate (RMR)

    Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)

  • Body composition

    Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)

  • Cold stimulated glucose uptake into supraclavicular BAT

    Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)

  • SUV max in supraclavicular adipose tissue depot

    Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)

Study Arms (2)

Patients starting glucocorticoids

Patients starting a glucocorticoid therapy measuring primary and secondary endpoints before and after at least 4 weeks of treatment.

Diagnostic Test: Indirect calorimetryDiagnostic Test: Skin TemperatureDiagnostic Test: Dual energy X-ray Absorptiometry (DXA)Diagnostic Test: Blood SamplingDiagnostic Test: FDG-PETDiagnostic Test: Capillary glucoseDiagnostic Test: Biopsy of supraclavicular adipose tissue (optional)

Patients stopping glucocorticoids

Patients stopping a glucocorticoid therapy measuring primary and secondary endpoints before weaning off glucocorticoids and after a period of at least 3 months.

Diagnostic Test: Indirect calorimetryDiagnostic Test: Skin TemperatureDiagnostic Test: Dual energy X-ray Absorptiometry (DXA)Diagnostic Test: Blood SamplingDiagnostic Test: FDG-PETDiagnostic Test: Capillary glucoseDiagnostic Test: Biopsy of supraclavicular adipose tissue (optional)

Interventions

Indirect calorimetryDIAGNOSTIC_TEST

Resting energy expenditure

Patients starting glucocorticoidsPatients stopping glucocorticoids
Skin TemperatureDIAGNOSTIC_TEST

Temperature: supraclavicular, infraclavicular, abdominal, mid-thigh, non-dominant lower arm, middle finger tip, left lower leg, left dorsal foot, ear thermometer

Patients starting glucocorticoidsPatients stopping glucocorticoids
Dual energy X-ray Absorptiometry (DXA)DIAGNOSTIC_TEST

Body composition

Patients starting glucocorticoidsPatients stopping glucocorticoids
Blood SamplingDIAGNOSTIC_TEST

thyroid-stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), HbA1c, Fibroblast growth factor 21 (FGF21)

Patients starting glucocorticoidsPatients stopping glucocorticoids
FDG-PETDIAGNOSTIC_TEST

Dynamic PET scanning of the neck-region

Patients starting glucocorticoidsPatients stopping glucocorticoids
Capillary glucoseDIAGNOSTIC_TEST

Prior to fluorodeoxyglucose (FDG)-PET in order to avoid hyperglycemia

Patients starting glucocorticoidsPatients stopping glucocorticoids
Biopsy of supraclavicular adipose tissue (optional)DIAGNOSTIC_TEST

Ultrasound guided biopsy of the supraclavicular adipose tissue

Patients starting glucocorticoidsPatients stopping glucocorticoids

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients will be recruited via the outpatient clinics (endocrinology, rheumathology, ophthalmology, gastroenterology etc.) of the Basel University Hospital.

You may qualify if:

  • Planned therapy with at least 7.5 mg prednisone equivalent per day or higher for more than 28 days (group A)
  • Planned weaning off glucocorticoid therapy which lasted al least 28 days with a dosage of at least 7.5 mg prednisone (group B)
  • BMI 19-30 kg/m2
  • Informed Consent as documented by signature

You may not qualify if:

  • Insufficient thyroid hormone substitution in case of hypothyroidism
  • Uncontrolled diabetes mellitus (HbA1c \>7.5%)
  • Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer
  • Known hypersensitivity to cold, e.g. primary or secondary Raynaud's Syndrome
  • Known or suspected non-compliance
  • Abuse of alcohol or illicit drugs
  • Claustrophobia
  • 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
  • Enrolment into another study using ionizing radiation within the previous 12 months

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 Optional biopsy of supraclavicular BAT

MeSH Terms

Interventions

Skin TemperatureAbsorptiometry, PhotonBlood Specimen Collection

Intervention Hierarchy (Ancestors)

Body TemperaturePhysiological PhenomenaSkin Physiological PhenomenaIntegumentary System Physiological PhenomenaRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesSpecimen HandlingClinical Laboratory TechniquesPuncturesSurgical Procedures, Operative

Study Officials

  • Matthias Matthias, PD Dr. med

    Klinik Endokrinologie, Diabetes und Metabolismus

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2019

First Posted

May 14, 2019

Study Start

June 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations

CH(1)