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Completed

NCT Number: NCT01762540

Glucocorticoid Induced Whole Body Catabolisme

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.

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Key information

Age range

20 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Medical Research Laboratory, Clinical Institute of Medicine, Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glucocorticoids

Drug

Prednisolone 37.5 mg x1 for 5 days

Other names: Prednisolone

Calcium Supplement

Drug

Placebo

Other names: Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intracellular signaling of IGF-I under the influence/abscence of prednisolone.

    Time frame: day 5

    Tissue biopsy on day 5.

  2. Insulin sensitivity under the influence/abscence of prednisolone.

    Time frame: Day 5

    Hyperinsulinemic euglycemic clamp on day 5.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • The Ministry of Science, Technology and Innovation, Denmark

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 7, 2013
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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