Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate (GLACIER)

January 24, 2022 updated by: University Hospital, Basel, Switzerland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Brown adipose tissue (BAT) is a thermogenic tissue that can convert chemical energy directly into heat due to the expression of uncoupling protein 1 (UCP1) protein. Data from preclinical studies shows that glucocorticoids (GCs) inhibit the function of BAT. In clinical practice GCs are often administered due tue their antiinflammatory properties making the investigation of short term (e.g. one week) and long therm (several months) effects practically relevant. This study's objective is to evaluate the effect of glucocorticoid treatment on cold induced thermogenesis (CIT) in humans.

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • BS
      • Basel, BS, Switzerland, 4031
        • University Hospital Basel, Department of Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 calorimetry
Resting energy expenditure
Diagnostic test: Dual energy X-ray Absorptiometry (DXA)
Body composition
Diagnostic test: Skin Temperature
Temperature: supraclavicular, infraclavicular, abdominal, mid-thigh, non-dominant lower arm, middle finger tip, left lower leg, left dorsal foot, ear thermometer
Diagnostic test: Blood Sampling
thyroid-stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), HbA1c, Fibroblast growth factor 21 (FGF21)
Diagnostic test: FDG-PET
Dynamic PET scanning of the neck-region
Diagnostic test: Capillary glucose
Prior to fluorodeoxyglucose (FDG)-PET in order to avoid hyperglycemia
Diagnostic test: Biopsy of supraclavicular adipose tissue (optional)
Ultrasound guided biopsy of the supraclavicular adipose tissue
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 calorimetry
Resting energy expenditure
Diagnostic test: Dual energy X-ray Absorptiometry (DXA)
Body composition
Diagnostic test: Skin Temperature
Temperature: supraclavicular, infraclavicular, abdominal, mid-thigh, non-dominant lower arm, middle finger tip, left lower leg, left dorsal foot, ear thermometer
Diagnostic test: Blood Sampling
thyroid-stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), HbA1c, Fibroblast growth factor 21 (FGF21)
Diagnostic test: FDG-PET
Dynamic PET scanning of the neck-region
Diagnostic test: Capillary glucose
Prior to fluorodeoxyglucose (FDG)-PET in order to avoid hyperglycemia
Diagnostic test: Biopsy of supraclavicular adipose tissue (optional)
Ultrasound guided biopsy of the supraclavicular adipose tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cold-induced thermogenesis (CIT) under glucocorticoids
Time Frame: Change from glucocortoid start to +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting metabolic rate (RMR)
Time Frame: Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
Comparison of RMR of patients starting GCs or patients stopping GCs, measured by indirect calorimetry
Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
Body composition
Time Frame: Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
Comparison of body composition concerning muscle mass and fat mass, determined by DXA
Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
Cold stimulated glucose uptake into supraclavicular BAT
Time Frame: Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
Determination of 'standardized uptake value' (SUV) mean in two volumes of interest on the supraclavicular adipose tissue, after PET-CT
Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
SUV max in supraclavicular adipose tissue depot
Time Frame: Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
Determination of SUV max in the supraclavicular adipose tissue, after positron emission tomography (PET)-CT
Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

ETH Zurich

Investigators

  • Study Director: Matthias Matthias, PD Dr. med, Klinik Endokrinologie, Diabetes und Metabolismus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2019

Primary Completion (ACTUAL)

December 1, 2021

Study Completion (ACTUAL)

December 1, 2021

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

May 13, 2019

First Posted (ACTUAL)

May 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 24, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EKNZ 2017-01742

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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