Metabole effecten van behandeling met prednisolon metabolic effects of prednisolone
Conditions
Interventions
Participants will be randomized to one of the following groups: placebo,
prednisolone 7.5 mg/daily or prednisolone 30 mg /daily.
Treatment duration is 14 days.
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: For all participants: 1. signed informed consent 2. caucasian male 3. normal day-and night rythm For healthy volunteers: 1. Good health (from history, physical exams, blood tests) 2. fasting glucose 93 cm and at least 3 of the following criteria: - triglycerides > 1.7 mmol/L - HDL cholesterol 130/85 mmHg - disturbed glucose tolerance (definded as: fasting glucose between 5.6 en 6.1 mmol/L en 2 hr plasma glucose after oral glucose tolerance test
Exclusion criteria
Exclusion criteria: For all participants: 1. allergy for prednisolone 2. any other contra-indication for prednisolone use. 3. use of glucocorticoids in the past 3 months 4. Recent participation in a clinical trial 5. Blood donation in the past 3 months 6. (history of) alcohol or drugs abuse. 7. Not willing or able to sign the informed consent or not being able to understand the study information 8. smoking for healthy males: 1. any present disorder 2. any medication use, except for incidental use of analgesic agents 3. 1ste degree relative with type 2 diabetes 4. intensive physical activity (sport) > 2x/week. For males with the metabolic syndrome: 1. serious (pulmonary, liver, kidney) diseases 2. history of cardiovascular disease (such as MI or CVA) 3. psychiatric disorder 4. depression 5. any condition that interferes with the HPA axis 6. malignancy 7. other condition or usage of medication that may interfere with study endpoints of hypothesis. Eligibility will be assessed in each individual case by the research physician and internist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In PANTHEON-I, various aspects of beta-cell function will be studied after intravenous (combined eu- and hyperglycemic clamp with subsequent arginine stimulation) and orally (mixed-meal test) administered glucose. In PANTHEON-II, GC-induced changes in hepatic and peripheral insulin sensitivity and subsequent changes in intermediary metabolism/metabolic fluxes, such as rate of endogenous glucose production, lipolysis and proteolysis, and the underlying molecular mechanism, will be studied. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary outcomes of PANTHEON-I: 1. circulating biomarkers (plasma) 2. Microvascular function 3. Blood pressure 4. Molecular mechanisms Secundaire uitkomsten van PANTHEON-II betreffen de effecten van bovengenoemde interventie met prednisolon op: 1. circulating biomarkers (plasma) 2. Body composition 3. Blood pressure 4. body fat distribution 5. Molecular mechanisms | — |
Countries
Netherlands
Outcome results
None listed