Thermoregulation ImpairmentGLACIERNCT03949361
Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate
An observational study of Thermoregulation Impairment, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thermoregulation Impairment
- What is being tested?
- Indirect calorimetry, Skin Temperature and Dual energy X-ray Absorptiometry (DXA)
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2019to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited via the outpatient clinics (endocrinology, rheumathology, ophthalmology, gastroenterology etc.) of the Basel University Hospital.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Department of Endocrinology
Basel, Canton of Basel-City, 4031
About this study
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.
Read the 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.
- Conditions
- Thermoregulation Impairment
- Being tested
- Indirect calorimetry, Skin Temperature, Dual energy X-ray Absorptiometry (DXA), Blood Sampling, FDG-PET
- Keywords
- Glucocorticoids, Brown Adipose tissue, Cold Induced Thermogenesis, Resting Metabolic Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect calorimetryDiagnostic test
Resting energy expenditure
Skin TemperatureDiagnostic test
Temperature: supraclavicular, infraclavicular, abdominal, mid-thigh, non-dominant lower arm, middle finger tip, left lower leg, left dorsal foot, ear thermometer
Dual energy X-ray Absorptiometry (DXA)Diagnostic test
Body composition
Blood SamplingDiagnostic test
thyroid-stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), HbA1c, Fibroblast growth factor 21 (FGF21)
FDG-PETDiagnostic test
Dynamic PET scanning of the neck-region
Capillary glucoseDiagnostic test
Prior to fluorodeoxyglucose (FDG)-PET in order to avoid hyperglycemia
Biopsy of supraclavicular adipose tissue (optional)Diagnostic test
Ultrasound guided biopsy of the supraclavicular adipose tissue
| Study group | Role | What they receive |
|---|---|---|
| Patients starting glucocorticoids | Patients starting a glucocorticoid therapy measuring primary and secondary endpoints before and after at least 4 weeks of treatment. Receives: Diagnostic Test: Indirect calorimetry; Diagnostic Test: Skin Temperature; Diagnostic Test: Dual energy X-ray Absorptiometry (DXA); Diagnostic Test: Blood Sampling; Diagnostic Test: FDG-PET; Diagnostic Test: Capillary glucose; Diagnostic 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. Receives: Diagnostic Test: Indirect calorimetry; Diagnostic Test: Skin Temperature; Diagnostic Test: Dual energy X-ray Absorptiometry (DXA); Diagnostic Test: Blood Sampling; Diagnostic Test: FDG-PET; Diagnostic Test: Capillary glucose; Diagnostic Test: Biopsy of supraclavicular adipose tissue (optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Comparison of RMR of patients starting GCs or patients stopping GCs, measured by indirect calorimetry
Measured: Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
Body composition
Comparison of body composition concerning muscle mass and fat mass, determined by DXA
Measured: Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
Cold stimulated glucose uptake into supraclavicular BAT
Determination of 'standardized uptake value' (SUV) mean in two volumes of interest on the supraclavicular adipose tissue, after PET-CT
Measured: Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
SUV max in supraclavicular adipose tissue depot
Determination of SUV max in the supraclavicular adipose tissue, after positron emission tomography (PET)-CT
Measured: Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 Jun 2019
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermoregulation ImpairmentStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich
- Responsible party
- Sponsor
- Investigators
- Matthias Matthias, PD Dr. med, Study director, Klinik Endokrinologie, Diabetes und Metabolismus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949361
- Sponsor's protocol ID
- EKNZ 2017-01742
- Acronym
- GLACIER
- Status last verified
- Jan 2022
- First submitted
- 2 Apr 2019
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate
- ClinicalTrials.gov ID
- NCT03949361
- Acronym / sponsor ID
- GLACIER / EKNZ 2017-01742
- Conditions
- Thermoregulation Impairment
- Keywords
- Glucocorticoids, Brown Adipose tissue, Cold Induced Thermogenesis, Resting Metabolic Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- ETH Zurich
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients starting glucocorticoids | – | Diagnostic Test: Indirect calorimetry, Diagnostic Test: Skin Temperature, Diagnostic Test: Dual energy X-ray Absorptiometry (DXA), Diagnostic Test: Blood Sampling, Diagnostic Test: FDG-PET, Diagnostic Test: Capillary glucose, Diagnostic Test: Biopsy of supraclavicular adipose tissue (optional)Patients starting a glucocorticoid therapy measuring primary and secondary endpoints before and after at least 4 weeks of treatment. |
| Patients stopping glucocorticoids | – | Diagnostic Test: Indirect calorimetry, Diagnostic Test: Skin Temperature, Diagnostic Test: Dual energy X-ray Absorptiometry (DXA), Diagnostic Test: Blood Sampling, Diagnostic Test: FDG-PET, Diagnostic Test: Capillary glucose, Diagnostic Test: Biopsy of supraclavicular adipose tissue (optional)Patients stopping a glucocorticoid therapy measuring primary and secondary endpoints before weaning off glucocorticoids and after a period of at least 3 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited via the outpatient clinics (endocrinology, rheumathology, ophthalmology, gastroenterology etc.) of the Basel University Hospital.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indirect calorimetryResting energy expenditure | Diagnostic test | Patients starting glucocorticoids, Patients stopping glucocorticoids |
| Skin TemperatureTemperature: supraclavicular, infraclavicular, abdominal, mid-thigh, non-dominant lower arm, middle finger tip, left lower leg, left dorsal foot, ear thermometer | Diagnostic test | Patients starting glucocorticoids, Patients stopping glucocorticoids |
| Dual energy X-ray Absorptiometry (DXA)Body composition | Diagnostic test | Patients starting glucocorticoids, Patients stopping glucocorticoids |
| Blood Samplingthyroid-stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), HbA1c, Fibroblast growth factor 21 (FGF21) | Diagnostic test | Patients starting glucocorticoids, Patients stopping glucocorticoids |
| FDG-PETDynamic PET scanning of the neck-region | Diagnostic test | Patients starting glucocorticoids, Patients stopping glucocorticoids |
| Capillary glucosePrior to fluorodeoxyglucose (FDG)-PET in order to avoid hyperglycemia | Diagnostic test | Patients starting glucocorticoids, Patients stopping glucocorticoids |
| Biopsy of supraclavicular adipose tissue (optional)Ultrasound guided biopsy of the supraclavicular adipose tissue | Diagnostic test | Patients starting glucocorticoids, Patients stopping glucocorticoids |
Primary outcome
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)
4 secondary outcomes
Resting metabolic rate (RMR)
Time frame: 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.)
Cold stimulated glucose uptake into supraclavicular BAT
Time frame: 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.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Matthias, PD Dr. med study director
Klinik Endokrinologie, Diabetes und Metabolismus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thermoregulation Impairment, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.