Glucocorticoid-induced inhibition of IGF-I activity: exploration of underlying mechanisms.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003504-12-DK

Enrollment

Unknown

Registered

2012-10-05

Start date

2012-10-05

Completion date

Unknown

Last updated

2016-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The catabolic effects induced by long-term glucocorticoid treatment.

Interventions

Trade Name: Prednisolon 25mg Pharmaceutical Form: Tablet INN or Proposed INN: PREDNISOLONE CAS Number: 50-24-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 37,5m

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Denmark

Contacts

Public ContactMedical Research Laboratory

Clinical Institute of Medicine, Aarhus University Hospital

004578461615

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026