Glucocorticoid Induced Whole Body Catabolisme

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT01762540

Collaborator

The Ministry of Science, Technology and Innovation, Denmark (Other)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Whole Body Catabolisme Induced by Glucocorticoids	Drug: Glucocorticoids Drug: Calcium Supplement	Phase 2

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

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Calcium supplement Capsule with tablet of calclium supplement	Drug: Calcium Supplement Placebo Other Names: Placebo
Active Comparator: Glucocorticoids Capsule with tablet of Prednisolone 37,5mg	Drug: Glucocorticoids Prednisolone 37.5 mg x1 for 5 days Other Names: Prednisolone

Arm

Intervention/Treatment

Placebo Comparator: Calcium supplement

Capsule with tablet of calclium supplement

Drug: Calcium Supplement

Placebo

Other Names:

Placebo

Active Comparator: Glucocorticoids

Capsule with tablet of Prednisolone 37,5mg

Drug: Glucocorticoids

Prednisolone 37.5 mg x1 for 5 days

Other Names:

Prednisolone

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.