Glucocorticoid Induced Whole Body Catabolisme
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01762540|
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : January 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Whole Body Catabolisme Induced by Glucocorticoids||Drug: Glucocorticoids Drug: Calcium Supplement||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|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 :||January 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Placebo Comparator: Calcium supplement
Capsule with tablet of calclium supplement
Drug: Calcium Supplement
Other Name: Placebo
Active Comparator: Glucocorticoids
Capsule with tablet of Prednisolone 37,5mg
Prednisolone 37.5 mg x1 for 5 days
Other Name: Prednisolone
- Insulin-like Growth Factor (IGF)-I profiles of subjects before and after prednisolone-treatment. [ Time Frame: day 1, 3 and 5 ]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 ]Tissue biopsy on day 5.
- Insulin sensitivity under the influence/abscence of prednisolone. [ Time Frame: Day 5 ]Hyperinsulinemic euglycemic clamp on day 5.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762540
|Medical Research Laboratory, Clinical Institute of Medicine, Aarhus University Hospital|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Jan Frystyk, Professor||Medical Research Laboratory, Clinical institute of Medicine, Aarhus University Hospital|