The peripheral effects of prednisolone on glucose metabolism, metabolic hormones, insulin sensitivity and insulin secretion in healthy young males and males with metabolic syndrome * two randomized, placebo controlled, double blind, dose-response, parallel group intervention studies. - PANTHEON-studies

Vrije Universiteit Medisch Centrum0 个研究点目标入组 124 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

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•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 < 5.6 mmol/L
•3. 20 < BMI< 25.
•4. 20 < age < 55 jaar.
•For subjects with the metabolic syndrome:
•1. metabolic syndrome (according to IDF criteria). Waist > 93 cm and at least 3 of the following criteria:
•- triglycerides > 1.7 mmol/L
•- HDL cholesterol < 1.03 mmol/L
•- blood pressure > 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 < 11.0 mmol/L).

•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.

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