CIRcadian Rhythms and CortisoL. Effects on Substrate Metabolism and Clock Gene Expression and Functioning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Sleeping RER
研究概览
简要总结
The aim of this project is to study the effects of exogenous glucocorticoid exposure on substrate metabolism, energy expenditure and correlates of circadian rhythmicity in healthy adults. The hypotheses are:
Short-term high dose glucocorticoid exposure in healthy subjects disrupts:
- The inherent circadian pattern of the respiratory exchange ratio and REE
- Sleep quality, appetite and food intake
- Clock gene expression and function in adipose tissue, skeletal muscle and blood leukocytes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI 20-30 kg/m2
- •Written informed consent
排除标准
- •Any chronic disease requiring daily medication excluding atopic skin or hay fever
- •Alcohol consumption >21 units per week
- •Strong CYP3A4 inhibitors or inducers
- •Use of glucocorticoid (GC) formulations: Inhaled corticosteroids, intra-articular or intramuscular injections, steroid creams European steroid group IV-V used in the genital area
- •Permitted glucocorticoid formulations: eye-drops, nasal spray, GC creams European steroid group I-III, and European steroid group IV-V used in the non-genital area only
- •Shift work
- •Severe claustrophobia
- •Use of melatonin
- •Previous diagnosis of a sleep disorder
- •Known severe sleep apnea (>30 respiration breaks/hour over 10 seconds)
- •Deemed unable to complete the study safely by investigator
研究组 & 干预措施
Prednisolone first, then placebo
Prednisolone 12.5 mg twice daily for 5 days. Placebo twice daily for 5 days
干预措施: Prednisolone (Drug)
Prednisolone first, then placebo
Prednisolone 12.5 mg twice daily for 5 days. Placebo twice daily for 5 days
干预措施: Placebo (Other)
Placebo first, then prednisolone
Placebo twice daily for 5 days Prednisolone 12.5 mg twice daily for 5 days.
干预措施: Prednisolone (Drug)
Placebo first, then prednisolone
Placebo twice daily for 5 days Prednisolone 12.5 mg twice daily for 5 days.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Sleeping RER
时间窗: Study day 1 and 2 (7 weeks apart)
Change in respiratory exchange ratio (RER) during sleep between placebo and prednisolone
Change in TEE
时间窗: Study day 1 and 2 (7 weeks apart)
Change in Total Energy Expenditure between placebo and prednisolone
Change in REE
时间窗: Study day 1 and 2 (7 weeks apart)
Change in Resting Energy Expenditure between placebo and prednisolone and morning/evening
Change in RER from fasting to feeding
时间窗: Study day 1 and 2 (7 weeks apart)
Change in respiratory exchange ratio (RER) after standard meal between placebo and prednisolone and morning/evening
次要结局
- Change in DIT(Study day 1 and 2 (7 weeks apart))
- Change in clock gene mRNA levels leukocytes(Study day 1 and 2 (7 weeks apart))
- Change in clock gene mRNA levels adipose tissue(Study day 1 and 2 (7 weeks apart))
- Change in GIP levels(Study day 1 and 2 (7 weeks apart))
- Change in Insulin levels(Study day 1 and 2 (7 weeks apart))
- Change in Glucagon levels(Study day 1 and 2 (7 weeks apart))
- Change in Gastrin levels(Study day 1 and 2 (7 weeks apart))
- Change in SEE(Study day 1 and 2 (7 weeks apart))
- Change in PAEE(Study day 1 and 2 (7 weeks apart))
- Change in fasting lipid oxidation rates(Study day 1 and 2 (7 weeks apart))
- Change in fasting glucose oxidation rates(Study day 1 and 2 (7 weeks apart))
- Change in protein oxidation rates from fasting to fed(Study day 1 and 2 (7 weeks apart))
- Change in sleep quality(Study day 1 and 2 (7 weeks apart))
- Change in HADS(Intervention period 1 and 2 (7 weeks apart))
- Change in clock gene mRNA levels skeletal muscle(Study day 1 and 2 (7 weeks apart))
- Change in appetite(Study day 1 and 2 (7 weeks apart))
- Change in ad libitum food intake(Study day 1 and 2 (7 weeks apart))
- Change in food intake at home(Intervention period 1 and 2 (7 weeks apart))
- Change in lipid oxidation rates from fasting to fed(Study day 1 and 2 (7 weeks apart))
- Change in glucose oxidation rates from fasting to fed(Study day 1 and 2 (7 weeks apart))
- Change in LEAP-2 levels(Study day 1 and 2 (7 weeks apart))
- Change in fasting protein oxidation rates(Study day 1 and 2 (7 weeks apart))
- Change in ghrelin levels(Study day 1 and 2 (7 weeks apart))
- Change in GLP-1 levels(Study day 1 and 2 (7 weeks apart))
- Change in Glucose levels(Study day 1 and 2 (7 weeks apart))
- Change in CCK levels(Study day 1 and 2 (7 weeks apart))
- Change in cortisol levels(Study day 1 and 2 (7 weeks apart))
- Change in FAP cells in skeletal muscle(Study day 1 and 2 (7 weeks apart))
- Change in FAP cells in adipose tissue(Study day 1 and 2 (7 weeks apart))
- Change in physical activity levels(Intervention period 1 and 2 (7 weeks apart))
- Change in IPAQ-7(Intervention period 1 and 2 (7 weeks apart))
- Change in sleep quality (measured)(Intervention period 1 and 2 (7 weeks apart))
- Change in sleep quality (reported)(Intervention period 1 and 2 (7 weeks apart))