NCT00971724

Brief Summary

Primary objective:

  • To identify a biomarker or biomarker-set for the adverse metabolic effects of various doses of prednisolone treatment. Secondary objectives:
  • To describe the PK of prednisolone and PD of a series of biomarkers.
  • To identify biomarkers that reflect side effects of prednisolone.
  • To elucidate part of the mechanisms by which prednisolone induces metabolic changes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

Typical duration for not_applicable

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

May 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

5 months

First QC Date

September 3, 2009

Last Update Submit

May 21, 2015

Conditions

Insulin ResistanceHyperglycemiaGlucose Intolerance

Keywords

PrednisoloneGlucocorticoids

Outcome Measures

Primary Outcomes (1)

  • To identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone

    Day 1 and day 15

Secondary Outcomes (1)

  • To describe the PK of prednisolone and PD of a series of biomarkers

    Day 1 and day 15

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Treatment with placebo for 15 days

Drug: Placebo

Prednisolone 7.5 mg daily

EXPERIMENTAL

Treatment with prednisolone 7.5 mg daily for 15 days

Drug: Prednisolone

Prednisolone 15 mg daily

EXPERIMENTAL

Treatment with prednisolone 15 mg daily for 15 days

Drug: Prednisolone

Prednisolone 30 mg daily

EXPERIMENTAL

Treatment with prednisolone 30 mg daily for 15 days

Drug: Prednisolone

Prednisolone 75 mg

EXPERIMENTAL

Treatment with prednisolone 75 mg for a single day

Drug: Prednisolone

Prednisolone 15 mg twice daily

EXPERIMENTAL

Treatment with prednisolone 15 mg twice daily for a single day

Drug: Prednisolone

Interventions

PlaceboDRUG

Oral administration, once daily, for 15 days

Placebo
PrednisoloneDRUG

Oral administration

Prednisolone 15 mg dailyPrednisolone 15 mg twice dailyPrednisolone 30 mg dailyPrednisolone 7.5 mg dailyPrednisolone 75 mg

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \< BMI \< 30
  • fasting glucose \< 5.6 mmol/L and glucose \< 7.8 mmol/L 2hr after OGTT
  • able and willing to sign informed consent
  • history of good physical and mental health
  • subject smokes less than 5 cigarettes per day
  • able to keep a normal day and night rhythm

You may not qualify if:

  • allergy to prednisolone
  • glucocorticoid use during last 3 months prior to study
  • use of any drug or substance
  • history of familiar diabetes type 2
  • clinically relevant history or presence of any medical disorder
  • clinically relevant abnormal lab or ECG
  • positive drug or alcohol screen, positive hepatitis B or C surface antigen
  • donation of blood (\>100 mL) within 90 days prior to the first dose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Ellero-Simatos S, Szymanska E, Rullmann T, Dokter WH, Ramaker R, Berger R, van Iersel TM, Smilde AK, Hankemeier T, Alkema W. Assessing the metabolic effects of prednisolone in healthy volunteers using urine metabolic profiling. Genome Med. 2012 Nov 30;4(11):94. doi: 10.1186/gm395. eCollection 2012.

    PMID: 23199229DERIVED

  • Toonen EJ, Fleuren WW, Nassander U, van Lierop MJ, Bauerschmidt S, Dokter WH, Alkema W. Prednisolone-induced changes in gene-expression profiles in healthy volunteers. Pharmacogenomics. 2011 Jul;12(7):985-98. doi: 10.2217/pgs.11.34. Epub 2011 Jun 2.

    PMID: 21635145DERIVED

MeSH Terms

Conditions

Insulin ResistanceHyperglycemiaGlucose Intolerance

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2009

First Posted

September 4, 2009

Study Start

May 1, 2006

Primary Completion

October 1, 2006

Study Completion

March 1, 2008

Last Updated

May 22, 2015

Record last verified: 2015-05