NCT01762540

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2013

Enrollment Period

1.4 years

First QC Date

January 3, 2013

Last Update Submit

January 7, 2016

Conditions

Whole Body Catabolisme Induced by Glucocorticoids

Keywords

Protein breakdownInsulin resistanceGlucose intoleranceLipolysis

Outcome Measures

Primary Outcomes (1)

  • Insulin-like Growth Factor (IGF)-I profiles of subjects before and after prednisolone-treatment.

    Blood-test before (day 1) during (day 3) and at the end (day 5) of placebo/prednisolone treatment.

    day 1, 3 and 5

Secondary Outcomes (2)

  • Intracellular signaling of IGF-I under the influence/abscence of prednisolone.

    day 5

  • Insulin sensitivity under the influence/abscence of prednisolone.

    Day 5

Study Arms (2)

Calcium supplement

PLACEBO COMPARATOR

Capsule with tablet of calclium supplement

Drug: Calcium Supplement

Glucocorticoids

ACTIVE COMPARATOR

Capsule with tablet of Prednisolone 37,5mg

Drug: Glucocorticoids

Interventions

GlucocorticoidsDRUG

Prednisolone 37.5 mg x1 for 5 days

Also known as: Prednisolone
Glucocorticoids
Calcium SupplementDRUG

Placebo

Also known as: Placebo
Calcium supplement

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • signed and dated informed consent
  • healthy subjects
  • sex: male
  • age 20-30 years
  • BMI 19-26 kg/m2
  • normal HbA1c

You may not qualify if:

  • 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
  • Participation in a larger X-ray examinations in trial period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Laboratory, Clinical Institute of Medicine, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (2)

  • Ramshanker N, Jessen N, Voss TS, Pedersen SB, Jorgensen JOL, Nielsen TS, Frystyk J, Moller N. Effects of short-term prednisolone treatment on indices of lipolysis and lipase signaling in abdominal adipose tissue in healthy humans. Metabolism. 2019 Oct;99:1-10. doi: 10.1016/j.metabol.2019.06.013. Epub 2019 Jun 29.

    PMID: 31260678DERIVED

  • Ramshanker N, Aagaard M, Hjortebjerg R, Voss TS, Moller N, Jorgensen JOL, Jessen N, Bjerring P, Magnusson NE, Bjerre M, Oxvig C, Frystyk J. Effects of Prednisolone on Serum and Tissue Fluid IGF-I Receptor Activation and Post-Receptor Signaling in Humans. J Clin Endocrinol Metab. 2017 Nov 1;102(11):4031-4040. doi: 10.1210/jc.2017-00696.

    PMID: 28945869DERIVED

MeSH Terms

Conditions

Insulin ResistanceGlucose Intolerance

Interventions

GlucocorticoidsPrednisolone

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperglycemia

Intervention Hierarchy (Ancestors)

Adrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jan Frystyk, Professor

    Medical Research Laboratory, Clinical institute of Medicine, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 7, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

January 8, 2016

Record last verified: 2013-01

Locations

DK(1)