Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Cold-induced thermogenesis (CIT) under glucocorticoids
研究概览
简要总结
The aim of the study is to investigate whether treatment with glucocorticoids leads to a change in heat production of the human body at mild cold conditions.
详细描述
Brown adipose tissue (BAT) is a thermogenic tissue that can convert chemical energy directly into heat due to the expression of uncoupling protein 1 (UCP1) protein. Data from preclinical studies shows that glucocorticoids (GCs) inhibit the function of BAT. In clinical practice GCs are often administered due tue their antiinflammatory properties making the investigation of short term (e.g. one week) and long therm (several months) effects practically relevant. This study's objective is to evaluate the effect of glucocorticoid treatment on cold induced thermogenesis (CIT) in humans.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned therapy with at least 7.5 mg prednisone equivalent per day or higher for more than 28 days (group A)
- •Planned weaning off glucocorticoid therapy which lasted al least 28 days with a dosage of at least 7.5 mg prednisone (group B)
- •BMI 19-30 kg/m2
- •Informed Consent as documented by signature
排除标准
- •Insufficient thyroid hormone substitution in case of hypothyroidism
- •Uncontrolled diabetes mellitus (HbA1c >7.5%)
- •Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer
- •Known hypersensitivity to cold, e.g. primary or secondary Raynaud's Syndrome
- •Known or suspected non-compliance
- •Abuse of alcohol or illicit drugs
- •Claustrophobia
- •Women who are pregnant or breast feeding
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc of the participant
- •Previous enrolment into the current study
- •Enrolment into another study using ionizing radiation within the previous 12 months
结局指标
主要结局
Cold-induced thermogenesis (CIT) under glucocorticoids
时间窗: Change from glucocortoid start to +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)
Comparison of CIT change off-glucocorticoids with warm ischemia time (WIT) on-glucocorticoids by using indirect calorimetry. Comparing two Groups (Observation group A and B) we will address the CIT change from glucocorticoid start to 4-8 weeks into treatment (group A) and the CIT change from glucocorticoid therapy to weaning off upon more than 3 months after glucocorticoid withdrawal (group B)
次要结局
- Body composition(Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.))
- SUV max in supraclavicular adipose tissue depot(Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.))
- Resting metabolic rate (RMR)(Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.))
- Cold stimulated glucose uptake into supraclavicular BAT(Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.))