Glucocorticoid Induced Whole Body Catabolisme

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University of Aarhus

Status and phase

Completed
Phase 2

Conditions

Whole Body Catabolisme Induced by Glucocorticoids

Treatments

Drug: Glucocorticoids
Drug: Calcium Supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT01762540
GK_nilani_2012

Details and patient eligibility

About

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.

Full 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

Enrollment

19 patients

Sex

Male

Ages

20 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

19 participants in 2 patient groups, including a placebo group

Calcium supplement
Placebo Comparator group
Description:
Capsule with tablet of calclium supplement
Treatment:
Drug: Calcium Supplement
Glucocorticoids
Active Comparator group
Description:
Capsule with tablet of Prednisolone 37,5mg
Treatment:
Drug: Glucocorticoids

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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