Glucocorticoid Induced Whole Body Catabolisme

Whole Body Catabolisme Induced by Glucocorticoids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762540
• Other study ID #: GK_nilani_2012
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2013
• Last updated: January 7, 2016
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Whole Body Catabolisme Induced by Glucocorticoids

Intervention

Drug:
• Glucocorticoids
Prednisolone 37.5 mg x1 for 5 days
• Calcium Supplement
Placebo

Locations

Country	Name	City	State
Denmark	Medical Research Laboratory, Clinical Institute of Medicine, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin-like Growth Factor (IGF)-I profiles of subjects before and after prednisolone-treatment.	Blood-test before (day 1) during (day 3) and at the end (day 5) of placebo/prednisolone treatment.	day 1, 3 and 5	No
Secondary	Intracellular signaling of IGF-I under the influence/abscence of prednisolone.	Tissue biopsy on day 5.	day 5	No
Secondary	Insulin sensitivity under the influence/abscence of prednisolone.	Hyperinsulinemic euglycemic clamp on day 5.	Day 5	No