Glucocorticoid Induced Whole Body Catabolisme

Phase 2

Completed

• Conditions: Whole Body Catabolisme Induced by Glucocorticoids
• Interventions: Drug: Calcium Supplement; Drug: Glucocorticoids

• Registration Number: NCT01762540
• Lead Sponsor: University of Aarhus

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2013-01
• Study Start: 2013-01
• Study First Submitted: 2013-01-03
• Study First Submitted QC: 2013-01-04
• Study First Posted: 2013-01-07
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

Inclusion Criteria

• signed and dated informed consent
• healthy subjects
• sex: male
• age 20-30 years
• BMI 19-26 kg/m2
• normal HbA1c

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Calcium supplement	Calcium Supplement	Capsule with tablet of calclium supplement
Glucocorticoids	Glucocorticoids	Capsule with tablet of Prednisolone 37,5mg

Primary Outcome Measures

Name	Time	Method
Insulin-like Growth Factor (IGF)-I profiles of subjects before and after prednisolone-treatment.	day 1, 3 and 5	Blood-test before (day 1) during (day 3) and at the end (day 5) of placebo/prednisolone treatment.

Secondary Outcome Measures

Name	Time	Method
Intracellular signaling of IGF-I under the influence/abscence of prednisolone.	day 5	Tissue biopsy on day 5.
Insulin sensitivity under the influence/abscence of prednisolone.	Day 5	Hyperinsulinemic euglycemic clamp on day 5.

Trial Locations

Locations (1)

Medical Research Laboratory, Clinical Institute of Medicine, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark