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临床试验/ISRCTN83991850
ISRCTN83991850已完成未知

PANTHEON-II: 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 60 人开始时间: 2007年7月3日最近更新:
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适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
60
研究概览入排标准研究者记录与标识符相似试验

研究概览

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

研究者

发起方
Vrije University Medical Centre (VUMC) (The Netherlands)

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