NL-OMON31204已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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).
排除标准
- •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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