Glucocorticoid Induced Whole Body Catabolisme

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-06-30

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.

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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

Conditions

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Whole Body Catabolisme Induced by Glucocorticoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Calcium supplement

Capsule with tablet of calclium supplement

Group Type PLACEBO_COMPARATOR

Calcium Supplement

Intervention Type DRUG

Placebo

Glucocorticoids

Capsule with tablet of Prednisolone 37,5mg

Group Type ACTIVE_COMPARATOR

Glucocorticoids

Intervention Type DRUG

Prednisolone 37.5 mg x1 for 5 days

Interventions

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Glucocorticoids

Prednisolone 37.5 mg x1 for 5 days

Intervention Type DRUG

Calcium Supplement

Placebo

Intervention Type DRUG

Other Intervention Names

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Prednisolone Placebo

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes