Short Term Effect of Glucocorticoids on Brown Adipose Tissue Thermogenesis in Humans
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Cold induced thermogenesis
研究概览
简要总结
Interventional, Placebo controlled cross-over study to investigate the short-term effects of glucocorticoids (prednisone) on human brown adipose tissue.
详细描述
Active brown adipose tissue (BAT) has recently been unambiguously discovered in human adults. Active BAT increases energy expenditure and improves glucose tolerance. Pharmacological use of glucocorticoids (GCs) is widespread in clinical practice due to their high anti-inflammatory efficacy. While short-term administration even of high doses usually is well tolerated, long-term use of medium to high amounts of GCs leads to unfavorable metabolic changes, characterized by an increase in intra-abdominal fat mass, a decrease in muscle mass and insulin resistance.
In line with these well-known side-effects of GCs, several in vitro studies and animal models demonstrate an inhibiting effect of GCs on BAT thermogenesis.
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers
- •BMI between 19-27 kg/m2
排除标准
- •Cold induced thermogenesis of less than 5% basal metabolic rate (determined during screening visit)
- •Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- •History of depressive disorder, anxiety disorder
- •History of tuberculosis or latent infection
- •Increased intraocular pressure
- •History of peptic / gastrointestinal ulcer disease
- •Concomitant medication: Non-steroidal anti-inflammatory drugs (NSAID), other glucocorticoids, diuretics, antihypertensives, fibrates or statins, metformin
- •Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus),
- •Hypersensitivity to cold (e.g. Raynaud Syndrome)
- •Allergy to local anesthetic
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the study
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Previous enrolment into the current study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons,
- •Hypothyroidism without sufficient substitution
- •Claustrophobia
- •MRI incompatible implants
- •Enrolment into another study using ionizing radiation within the previous 12 months.
研究组 & 干预措施
Prednisone
Prednisone 40 mg daily for 7 days
干预措施: Prednisone (Drug)
Placebo
Placebo daily for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Cold induced thermogenesis
时间窗: at the end of each treatment period (day 7). Prednisone vs. Placebo
: Increase in energy expenditure above resting metabolic rate in response to a mild cold stimulus determined by indirect calorimetry
次要结局
- fat fraction of supraclavicular BAT(at the end of each treatment period (day 7). Prednisone vs. Placebo)
- volume of supraclavicular BAT(at the end of each treatment period (day 7). Prednisone vs. Placebo)
- cold stimulated FGD uptake in brown adipose tissue(at the end of each treatment period (day 7). Prednisone vs. Placebo)
- SUVmax in the supraclavicular adipose tissue depot(at the end of each treatment period (day 7). Prednisone vs. Placebo)