ISRCTN78149983已完成不适用
PANTHEON-I: The peripheral effects of prednisolone on glucose metabolism, metabolic hormones, insulin sensitivity and insulin secretion in healthy young males and males with metabolic syndrome: a randomised, placebo controlled, double blind, dose-response, parallel group intervention study
Vrije University Medical Centre (VUMC) (The Netherlands)0 个研究点目标入组 64 人开始时间: 2007年7月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
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
- 性别
- Male
入选标准
- •For all participants:
- •1. Written informed consent
- •2. Male caucasian
- •3. Smoking less than five cigarettes per day and capable of stopping during the trial period
- •For healthy participants:
- •1. Healthy as determined by history taking, physical examination, laboratory examinations and Electrocardiogram (ECG):
- •1.1. Aged 20 to 55 years
- •1.2. Body Mass Index (BMI) between 20 and 25 kg/m^2
- •1.3. Fasting glucose less than 5.6 mmol/L and glucose less than 7.8 mmol/L at two hours after intake of 75 g glucose (Oral Glucose Tolerance Test [OGTT])
- •For participants with metabolic syndrome:
- •1. Aged 20 to 55 years
- •2. Waist circumference more than 94 cm
- •3. Three of following criteria:
- •3.1. Triglycerides more than 1.7 mmol/L
- •3.2. High Density Lipoprotein (HDL) cholesterol less than 1.03 mmol/L
- •3.3. Blood pressure more than 130/85 mmHg
- •3.4. Fasting glucose level less than 6.1 mmol/L and glucose less than 11.0 mmol/L at two hours after intake of 75 g glucose (OGTT)
排除标准
- •For all participants:
- •1. Idiosyncrasy/sensitivity to Glucocorticoids (GC)
- •2. GC use during the last three months prior to first study dose
- •3. Participation in an investigational drug trial within 90 days prior to the first dose
- •4. Donation of blood (more than 100 mL) within 90 days prior to the first dose
- •5. History of or current abuse of drugs or alcohol
- •6. Serious mental impairment or language problems, i.e., preventing to understand the study protocol/aim
- •For healthy participants:
- •1. Presence of a medical disorder
- •2. Medication use, except for incidental analgesic agents
- •3. First degree relative with type two diabetes mellitus
- •4. Performing intensive physical activity more than twice a week
- •For participants with metabolic syndrome:
- •1. Serious pulmonary, cardiovascular, hepatic (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST] more than 3 x Upper Limit of Normal [ULN]) or renal disease (serum creatinine more than 135 mmol/L)
- •2. History of cardiovascular disease, such as myocardial infarction, cerebrovascular accident
- •3. Major psychiatric disorder
- •4. Depression
- •5. All diseases that induce changes in the Hypothalamic-Pituitary-Adrenal (HPA) axis
- •6. Malignant disease
- •7. All other relevant medical disorders that potentially interfere with this trial*
- •8. All medication interfering with study drug or interfering with study endpoints/hypotheses*
- •* the study physician and internist will make an individual assessment per subject whether he is eligible for inclusion
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