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| Name | Class |
|---|---|
| ETH Zurich | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients starting glucocorticoids | Patients starting a glucocorticoid therapy measuring primary and secondary endpoints before and after at least 4 weeks of treatment. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indirect calorimetry | Diagnostic Test | Resting energy expenditure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Change from glucocortoid start to +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.) |
| Measure | Description | Time Frame |
|---|---|---|
| Resting metabolic rate (RMR) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited via the outpatient clinics (endocrinology, rheumathology, ophthalmology, gastroenterology etc.) of the Basel University Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Matthias, PD Dr. med | Klinik Endokrinologie, Diabetes und Metabolismus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel, Department of Endocrinology | Basel | Canton of Basel-City | 4031 | Switzerland |
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Serum and plasma Optional biopsy of supraclavicular BAT
| Skin Temperature | Diagnostic 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 Sampling | Diagnostic Test | thyroid-stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), HbA1c, Fibroblast growth factor 21 (FGF21) |
|
| FDG-PET | Diagnostic Test | Dynamic PET scanning of the neck-region |
|
| Capillary glucose | Diagnostic 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 |
|
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 | 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 | 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.) |
| ID | Term |
|---|---|
| D012881 | Skin Temperature |
| D015502 | Absorptiometry, Photon |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D001831 | Body Temperature |
| D010829 | Physiological Phenomena |
| D012879 | Skin Physiological Phenomena |
| D055827 | Integumentary System Physiological Phenomena |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
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