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| Name | Class |
|---|---|
| The Ministry of Science, Technology and Innovation, Denmark | OTHER_GOV |
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The main purpose of the trial is to advance our knowledge on the possible mechanism underlying the catabolic effects of long-term treatment with glucocorticoid.
Long-term treatment with glucocorticoid induces a general state of catabolism and increases insulin resistance. The underlying mechanisms are insufficiently characterized, however glucocorticoid induced changes of Growth Hormone (GH) and the Insulin-like growth factor I (IGF-I) appear to be of outmost importance.
We wish to investigate the mechanism behind glucocorticoid induced catabolism and insulin resistance.
More specific we wish to investigate:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium supplement | Placebo Comparator | Capsule with tablet of calclium supplement |
|
| Glucocorticoids | Active Comparator | Capsule with tablet of Prednisolone 37,5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucocorticoids | Drug | Prednisolone 37.5 mg x1 for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin-like Growth Factor (IGF)-I profiles of subjects before and after prednisolone-treatment. | Blood-test before (day 1) during (day 3) and at the end (day 5) of placebo/prednisolone treatment. | day 1, 3 and 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Intracellular signaling of IGF-I under the influence/abscence of prednisolone. | Tissue biopsy on day 5. | day 5 |
| Insulin sensitivity under the influence/abscence of prednisolone. | Hyperinsulinemic euglycemic clamp on day 5. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Frystyk, Professor | Medical Research Laboratory, Clinical institute of Medicine, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Research Laboratory, Clinical Institute of Medicine, Aarhus University Hospital | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31260678 | Derived | Ramshanker N, Jessen N, Voss TS, Pedersen SB, Jorgensen JOL, Nielsen TS, Frystyk J, Moller N. Effects of short-term prednisolone treatment on indices of lipolysis and lipase signaling in abdominal adipose tissue in healthy humans. Metabolism. 2019 Oct;99:1-10. doi: 10.1016/j.metabol.2019.06.013. Epub 2019 Jun 29. | |
| 28945869 | Derived |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005938 | Glucocorticoids |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
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| Calcium Supplement | Drug | Placebo |
|
|
| Day 5 |
| Ramshanker N, Aagaard M, Hjortebjerg R, Voss TS, Moller N, Jorgensen JOL, Jessen N, Bjerring P, Magnusson NE, Bjerre M, Oxvig C, Frystyk J. Effects of Prednisolone on Serum and Tissue Fluid IGF-I Receptor Activation and Post-Receptor Signaling in Humans. J Clin Endocrinol Metab. 2017 Nov 1;102(11):4031-4040. doi: 10.1210/jc.2017-00696. |
| D006943 | Hyperglycemia |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |