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Glucocorticoid Induced Whole Body Catabolisme

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01762540
First Posted: January 7, 2013
Last Update Posted: January 8, 2016
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.
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
University of Aarhus
  Purpose
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.

Condition Intervention Phase
Whole Body Catabolisme Induced by Glucocorticoids Drug: Glucocorticoids Drug: Calcium Supplement Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 19
Study Start Date: January 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Calcium supplement
Capsule with tablet of calclium supplement
Drug: Calcium Supplement
Placebo
Other Name: Placebo
Active Comparator: Glucocorticoids
Capsule with tablet of Prednisolone 37,5mg
Drug: Glucocorticoids
Prednisolone 37.5 mg x1 for 5 days
Other Name: Prednisolone

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Denmark
Medical Research Laboratory, Clinical Institute of Medicine, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
The Ministry of Science, Technology and Innovation, Denmark
Investigators
Principal Investigator: Jan Frystyk, Professor Medical Research Laboratory, Clinical institute of Medicine, Aarhus University Hospital
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01762540     History of Changes
Other Study ID Numbers: GK_nilani_2012
First Submitted: January 3, 2013
First Posted: January 7, 2013
Last Update Posted: January 8, 2016
Last Verified: January 2013

Keywords provided by University of Aarhus:
Protein breakdown
Insulin resistance
Glucose intolerance
Lipolysis

Additional relevant MeSH terms:
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Glucocorticoids
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents