Glucocorticoid Induced Whole Body Catabolisme

This study has been completed.
Sponsor:
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01762540
First received: January 3, 2013
Last updated: May 28, 2015
Last verified: January 2013
  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
Phase 2

Study Type: Interventional
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
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Tissue biopsy on day 5.

  • Insulin sensitivity under the influence/abscence of prednisolone. [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    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: Placebo
Capsule with tablet of calclium
Placebo 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

Ages Eligible for Study:   20 Years to 30 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01762540     History of Changes
Other Study ID Numbers: GK_nilani_2012
Study First Received: January 3, 2013
Last Updated: May 28, 2015
Health Authority: Denmark: Ethics Committee
Denmark: Danish Health and Medicines Authority

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

Additional relevant MeSH terms:
Glucocorticoids
Prednisolone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on August 30, 2015