Glucocorticoid Induced Whole Body Catabolisme

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Whether glucocorticoid induces IGF-I inhibiting substances in serum or interstitial fluid that block the ability of IGF-I to phosphorylate its receptor in vitro Whether glucocorticoid inhibits intracellular IGF-I and insulin signaling in vitro and in vivo The mechanisms by which growth hormone counteracts the CG-mediated inhibition of IGF-I action

Official Title
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Glucocorticoid Induced Inhibition of IGF-I Activity: Exploring Underlying Mechanisms.

Conditions
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Whole Body Catabolisme Induced by Glucocorticoids

Intervention / Treatment
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* Drug: Glucocorticoids
* Drug: Calcium Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed and dated informed consent healthy subjects sex: male age 20-30 years BMI 19-26 kg/m2 normal HbA1c Exclusion Criteria: suspected og known allergy to the trial drug or similar medications. known current illness including diabetes mellitus, ischemic heart disease or cardiac arrhythmia. Daily drug intake (excluding Over-the-Counter medicines). Known or previous mental illness Current participation or previous participation in experiments using ionizing radiation for a year prior to inclusion in this study. Participation in a larger X-ray examinations in trial period.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Calcium supplement<br>Capsule with tablet of calclium supplement | Drug: Calcium Supplement<br>* Placebo<br>* Other names: Placebo;|
| Active Comparator: Glucocorticoids<br>Capsule with tablet of Prednisolone 37,5mg | Drug: Glucocorticoids<br>* Prednisolone 37.5 mg x1 for 5 days<br>* Other names: Prednisolone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protein breakdown, Insulin resistance, Glucose intolerance, Lipolysis