Glucocorticoid Induced Whole Body Catabolisme

January 7, 2016 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Medical Research Laboratory, Clinical Institute of Medicine, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Calcium supplement
Capsule with tablet of calclium supplement
Drug: Calcium Supplement
Placebo
Other Names:
  • Placebo
ACTIVE_COMPARATOR: Glucocorticoids
Capsule with tablet of Prednisolone 37,5mg
Drug: Glucocorticoids
Prednisolone 37.5 mg x1 for 5 days
Other Names:
  • Prednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 1, 3 and 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracellular signaling of IGF-I under the influence/abscence of prednisolone.
Time Frame: day 5
Tissue biopsy on day 5.
day 5
Insulin sensitivity under the influence/abscence of prednisolone.
Time Frame: Day 5
Hyperinsulinemic euglycemic clamp on day 5.
Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

The Ministry of Science, Technology and Innovation, Denmark

Investigators

  • Principal Investigator: Jan Frystyk, Professor, Medical Research Laboratory, Clinical Institute of Medicine, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

January 3, 2013

First Submitted That Met QC Criteria

January 4, 2013

First Posted (ESTIMATE)

January 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GK_nilani_2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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