Glucocorticoid-induced inhibition of IGF-I activity: exploration of underlying mechanisms.
- Conditions
- The catabolic effects induced by long-term glucocorticoid treatment.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2012-003504-12-DK
- Lead Sponsor
- Medical Research Laboratory, Clinical institute of Medicine, Aarhus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Signed and dated informed consent
Healthy subjects
Sex: male
Age 20-30 years
BMI 19-26 kg/m2
normal HbA1c
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Suspected or known allergy to the trial drug or similar medications.
Known current illness including diabetes mellitus, ischemic heart disease or cardiac arrhytmia.
Daily drug intake (excluding OCT preparations).
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main purpose of the tríal is to advance our knowledge on the possible mechanism underlying the catabolic effects of long-term treatment with glucocorticoid. More specifically we are interested in the molecular mechanisms by which glucocorticoid inhibits growth.;Primary end point(s): GH and IGF-profiles of subjects before and after prednisolon-treatment. ;Timepoint(s) of evaluation of this end point: blood-test before (day 1) during (day 3) and at the end (day 5) of placebo/prednisolon treatment. ;Secondary Objective: To investigate the effect of glucocorticoid treatment on the activity of the circulating Insulin-like Growth Factor (IGF) system in healthy adults and intracellular in vitro and in vivo studies of IGF-I receptor phosphorylation and intracellular signaling in muscle and tissue biopsies. IGF levels in in serum vs. interstitiel fluid.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): insulin sensitivity and intracellulair signaling of IGF-I under the influence/abscence of prednisolon;Timepoint(s) of evaluation of this end point: hyperinsulinemic euglycemic clamp and tissue biopsi on day 5.