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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Aarhus
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: January 4, 2013
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. More specifically the investigators are interested in the molecular mechanisms by which glucocorticoid inhibits growth.


Condition Intervention Phase
Focus of Study: Prednisolone Induced Catabolic Effects
Drug: Prednisolone
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.


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo Comparator: Active
Prednisolone
Drug: Prednisolone

  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

Contacts
Contact: Nilani Ramshanker, Doctor +45 78462154 nilani.ramshanker@ki.au.dk
Contact: Jan Frystyk, Doctor +45 89492166 jan.frystyk@ki.au.dk

Locations
Denmark
Medical Research Laboratory, Clinical Institute of Medicine, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Nilani Ramshanker, Doctor    +45 78462154    nilani.ramshanker@ki.au.dk   
Contact: Jan Frystyk, Doctor    +45 89492166      
Principal Investigator: Nilani Ramshanker, Doctor         
Sponsors and Collaborators
University of Aarhus
The Ministry of Science, Technology and Innovation, Denmark
Investigators
Principal Investigator: Jan Frystyk, Doctor, 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: January 4, 2013
Health Authority: Denmark: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 01, 2014