Clinical trial NCT03949361: Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate
Official title: Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thermoregulation Impairment
Keywords: Glucocorticoids
Brown Adipose tissue
Cold Induced Thermogenesis
Resting Metabolic Rate
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: ETH Zurich
First posted: 2019-05-14
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited via the outpatient clinics (endocrinology, rheumathology, ophthalmology, gastroenterology etc.) of the Basel University Hospital.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cold-induced thermogenesis (CIT) under glucocorticoids
timeFrame: Change from glucocortoid start to +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
Secondary outcomes:
measure: Resting metabolic rate (RMR)
timeFrame: Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
measure: Body composition
timeFrame: Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
measure: Cold stimulated glucose uptake into supraclavicular BAT
timeFrame: Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
measure: SUV max in supraclavicular adipose tissue depot
timeFrame: Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Endocrinology
state: BS
Study officials:
affiliation: Klinik Endokrinologie, Diabetes und Metabolismus
name: Matthias Matthias, PD Dr. med
role: STUDY_DIRECTOR
References: