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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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The aim of this project is to study the effects of exogenous glucocorticoid exposure on substrate metabolism, energy expenditure and correlates of circadian rhythmicity in healthy adults. The hypotheses are:
Short-term high dose glucocorticoid exposure in healthy subjects disrupts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisolone first, then placebo | Experimental | Prednisolone 12.5 mg twice daily for 5 days. Placebo twice daily for 5 days |
|
| Placebo first, then prednisolone | Experimental | Placebo twice daily for 5 days Prednisolone 12.5 mg twice daily for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | see arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleeping RER | Change in respiratory exchange ratio (RER) during sleep between placebo and prednisolone | Study day 1 and 2 (7 weeks apart) |
| Change in TEE | Change in Total Energy Expenditure between placebo and prednisolone | Study day 1 and 2 (7 weeks apart) |
| Change in REE | Change in Resting Energy Expenditure between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in RER from fasting to feeding | Change in respiratory exchange ratio (RER) after standard meal between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PAEE | Change in Physical Activity related Energy Expenditure (PAEE) between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in SEE | Change in Sleeping Energy Expenditure (PAEE) between placebo and prednisolone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Otto L Jørgensen, Professor | Aarhus University Hospital | Study Director |
| Simon B Hansen, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology and Internal Medicine | Aarhus | State | 8200 | Denmark |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Placebo | Other | Placebo similar to prednisolone |
|
| Study day 1 and 2 (7 weeks apart) |
| Change in DIT | Change in diet-induced thermogenesis between placebo and prednisolone and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in clock gene mRNA levels leukocytes | Change in mRNA expression levels in blood leukocytes between placebo and prednisolone and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in clock gene mRNA levels adipose tissue | Change in mRNA expression levels in adipose tissue biopsies between placebo and prednisolone and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in clock gene mRNA levels skeletal muscle | Change in mRNA expression levels in skeletal muscle tissue biopsies between placebo and prednisolone and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in appetite | Measured by numerical rating scale on parameters hunger, fullness, satiety, desire and prospective consumption with values 1 (not at all) to 10 (maximally present) before and after ad libitum meal and standard meal, and between placebo and prednisolone and morning/evening. The scale is adapted from PMID: 20122136 | Study day 1 and 2 (7 weeks apart) |
| Change in ad libitum food intake | Measured by caloric intake between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in food intake at home | Measured by dietary registration during prednisolone and placebo | Intervention period 1 and 2 (7 weeks apart) |
| Change in fasting lipid oxidation rates | Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in lipid oxidation rates from fasting to fed | Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in glucose oxidation rates from fasting to fed | Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in fasting glucose oxidation rates | Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in fasting protein oxidation rates | Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in protein oxidation rates from fasting to fed | Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in ghrelin levels | Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in LEAP-2 levels | Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in GLP-1 levels | Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in GIP levels | Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in Glucose levels | Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in Insulin levels | Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in Glucagon levels | Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in Gastrin levels | Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in CCK levels | Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in cortisol levels | Measured successively over 24 hours in serum during study days | Study day 1 and 2 (7 weeks apart) |
| Change in FAP cells in skeletal muscle | Fibro-adipogenic progenitor cells levels and characteristics in skeletal muscle tissue biopsies between placebo and prednisolone and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in FAP cells in adipose tissue | Fibro-adipogenic progenitor cells levels and characteristics in adipose tissue biopsies between placebo and prednisolone and prednisolone and morning/evening | Study day 1 and 2 (7 weeks apart) |
| Change in physical activity levels | Measured by actigraph during study periods | Intervention period 1 and 2 (7 weeks apart) |
| Change in IPAQ-7 | Measured by Internation Physical Activity Questionnaire | Intervention period 1 and 2 (7 weeks apart) |
| Change in sleep quality (measured) | Measured by actigraph during study periods | Intervention period 1 and 2 (7 weeks apart) |
| Change in sleep quality (reported) | Measured by Pittsburgh Sleep Quality Index questionnaire | Intervention period 1 and 2 (7 weeks apart) |
| Change in sleep quality | Measured by polysomnography | Study day 1 and 2 (7 weeks apart) |
| Change in HADS | Measured by Hospital Anxiety and Depression Scale (HADS), a 14-question instrument with 7 questions measuring anxiety and 7 measuring depression. Each is scored between 0 (no impairment) and 3 (severe impairment) | Intervention period 1 and 2 (7 weeks apart) |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |