Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate
NCT ID: NCT03949361
Last Updated: 2022-01-25
Study Results
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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COMPLETED
7 participants
OBSERVATIONAL
2019-06-01
2021-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients starting glucocorticoids
Patients starting a glucocorticoid therapy measuring primary and secondary endpoints before and after at least 4 weeks of treatment.
Indirect calorimetry
Resting energy expenditure
Skin Temperature
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)
Body composition
Blood Sampling
thyroid-stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), HbA1c, Fibroblast growth factor 21 (FGF21)
FDG-PET
Dynamic PET scanning of the neck-region
Capillary glucose
Prior to fluorodeoxyglucose (FDG)-PET in order to avoid hyperglycemia
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.
Indirect calorimetry
Resting energy expenditure
Skin Temperature
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)
Body composition
Blood Sampling
thyroid-stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), HbA1c, Fibroblast growth factor 21 (FGF21)
FDG-PET
Dynamic PET scanning of the neck-region
Capillary glucose
Prior to fluorodeoxyglucose (FDG)-PET in order to avoid hyperglycemia
Biopsy of supraclavicular adipose tissue (optional)
Ultrasound guided biopsy of the supraclavicular adipose tissue
Interventions
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Indirect calorimetry
Resting energy expenditure
Skin Temperature
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)
Body composition
Blood Sampling
thyroid-stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), HbA1c, Fibroblast growth factor 21 (FGF21)
FDG-PET
Dynamic PET scanning of the neck-region
Capillary glucose
Prior to fluorodeoxyglucose (FDG)-PET in order to avoid hyperglycemia
Biopsy of supraclavicular adipose tissue (optional)
Ultrasound guided biopsy of the supraclavicular adipose tissue
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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ETH Zurich
OTHER
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Matthias Matthias, 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
Countries
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Other Identifiers
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EKNZ 2017-01742
Identifier Type: -
Identifier Source: org_study_id
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