Glucocorticoid Induced Whole Body Catabolisme

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01762540

Enrollment

Registered

2013-01-07

Start date

2013-01-31

Completion date

2014-06-30

Last updated

2016-01-08

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

Conditions

Whole Body Catabolisme Induced by Glucocorticoids

Keywords

Protein breakdown, Insulin resistance, Glucose intolerance, Lipolysis

Brief 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.

Detailed 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

Interventions

DRUGGlucocorticoids

Prednisolone 37.5 mg x1 for 5 days

DRUGCalcium Supplement

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 30 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Insulin-like Growth Factor (IGF)-I profiles of subjects before and after prednisolone-treatment.	day 1, 3 and 5	Blood-test before (day 1) during (day 3) and at the end (day 5) of placebo/prednisolone treatment.

Secondary

Measure	Time frame	Description
Intracellular signaling of IGF-I under the influence/abscence of prednisolone.	day 5	Tissue biopsy on day 5.
Insulin sensitivity under the influence/abscence of prednisolone.	Day 5	Hyperinsulinemic euglycemic clamp on day 5.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026