Glucocorticoid Induced Inhibition of IGF-I Activity: Exploring Underlying Mechanisms.
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. More specifically the investigators are interested in the molecular mechanisms by which glucocorticoid inhibits growth.
Focus of Study: Prednisolone Induced Catabolic Effects
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Glucocorticoid Induced Inhibition of IGF-I Activity: Exploring Underlying Mechanisms.|
- Insulin-like Growth Factor (IGF)-I profiles of subjects before and after prednisolone-treatment. [ Time Frame: day 1, 3 and 5 ] [ Designated as safety issue: No ]Blood-test before (day 1) during (day 3) and at the end (day 5) of placebo/prednisolone treatment.
- Intracellular signaling of IGF-I under the influence/abscence of prednisolone. [ Time Frame: day 5 ] [ Designated as safety issue: No ]Tissue biopsy on day 5.
- Insulin sensitivity under the influence/abscence of prednisolone. [ Time Frame: Day 5 ] [ Designated as safety issue: No ]Hyperinsulinemic euglycemic clamp on day 5.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo|
Placebo Comparator: Active
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762540
|Contact: Nilani Ramshanker, Doctor||+45 firstname.lastname@example.org|
|Contact: Jan Frystyk, Doctor||+45 email@example.com|
|Medical Research Laboratory, Clinical Institute of Medicine, Aarhus University Hospital||Recruiting|
|Aarhus, Denmark, 8000|
|Contact: Nilani Ramshanker, Doctor +45 78462154 firstname.lastname@example.org|
|Contact: Jan Frystyk, Doctor +45 89492166|
|Principal Investigator: Nilani Ramshanker, Doctor|
|Principal Investigator:||Jan Frystyk, Doctor, Professor||Medical Research Laboratory, Clinical institute of Medicine, Aarhus University Hospital|