Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate
- Conditions
- Thermoregulation Impairment
- Registration Number
- NCT03949361
- Lead Sponsor
- University Hospital, Basel, Switzerland
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cold-induced thermogenesis (CIT) under glucocorticoids 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)
- Secondary Outcome Measures
Name Time Method Body composition 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
SUV max in supraclavicular adipose tissue depot 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
Resting metabolic rate (RMR) 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
Cold stimulated glucose uptake into supraclavicular BAT 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
Trial Locations
- Locations (1)
University Hospital Basel, Department of Endocrinology
🇨🇭Basel, BS, Switzerland
University Hospital Basel, Department of Endocrinology🇨🇭Basel, BS, Switzerland