Biomarkers of Prednisolone Treatment (P05888)
Status
Completed
Conditions
Hyperglycemia
Insulin Resistance
Glucose Intolerance
Treatments
Drug: Placebo
Drug: Prednisolone
Details and patient eligibility
About
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.
Enrollment
72 patients
Sex
Male
Ages
20 to 45 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- 22 < 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
Exclusion criteria
- 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
72 participants in 6 patient groups, including a placebo group
Placebo
Placebo Comparator group
Description:
Treatment with placebo for 15 days
Treatment:
Drug: Placebo
Prednisolone 7.5 mg daily
Experimental group
Description:
Treatment with prednisolone 7.5 mg daily for 15 days
Treatment:
Drug: Prednisolone
Prednisolone 15 mg daily
Experimental group
Description:
Treatment with prednisolone 15 mg daily for 15 days
Treatment:
Drug: Prednisolone
Prednisolone 30 mg daily
Experimental group
Description:
Treatment with prednisolone 30 mg daily for 15 days
Treatment:
Drug: Prednisolone
Prednisolone 75 mg
Experimental group
Description:
Treatment with prednisolone 75 mg for a single day
Treatment:
Drug: Prednisolone
Prednisolone 15 mg twice daily
Experimental group
Description:
Treatment with prednisolone 15 mg twice daily for a single day
Treatment:
Drug: Prednisolone
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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