NCT05294965已完成早期 1 期
Beta 2 Adrenergic Stimulation vs Cold Exposure to Activate Human Brown Adipose Tissue
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年4月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- BAT SUVmean
研究概览
简要总结
The purpose of the study is to asses brown adipose tissue activity in humans after intravenous administration of the selective beta-2-adrenergic agonist fenoterol as compared to the natural activator of brown adipose tissue, a mild cold stimulus.
详细描述
The activation of brown adipose tissue in response to beta-2-adrenergic stimulation as compared to cold exposure will be studied in an open-label, cross-over trial in healthy volunteers with random sequence of the two study interventions a) and b):
- A bolus of 25µg fenoterol will be slowly injected intravenously during 2-3 minutes followed by a continuous infusion of fenoterol 1µg/min over 120 minutes. The total dose of fenoterol per subject will thus be 145µg.
- During 120 minutes participants will be exposed to a mild cold stimulus water using cooling sleeves, covering the participant's waist, is gradually decrease body surface temperature to 10 degrees or to the lowest tolerable temperature without shivering.
Energy expenditure will be measured during both interventions by indirect calorimetry and brown adipose tissue activity will determined by 18F-FDG-PET/CT 30 min after injection of 75 MBq of 18F-FDG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 18,5-23 kg/m2 or 30-35 kg/m2
排除标准
- •History or signs of any medical or psychological condition
- •pregnancy or lactation
- •medications except prescription free analgesics and contraceptives
- •habitual alcohol or tobacco use
- •weight change >5% within prior 3 months
- •Resting heart rate >85 bpm
- •Systolic blood pressure >140 mmHg or diastolic blood pressure <50 mmHg
- •Presence of following ECG changes: ST-segment deviations, QTc >500ms, signs of pre-excitation
- •Hyper- or Hypothyroidism
- •inability to follow study procedures
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •hypersensitivity to cold
- •enrolment into study with ionizing radiation within prior 12 months.
- •Cold induced thermogenesis of less than 5% basal metabolic rate and normal weight or cold induced thermogenesis of more than 5% and overweight (determined during screening visit)
研究组 & 干预措施
Normal weight
Experimental
- A bolus of 25µg fenoterol will be slowly injected intravenously during 2-3 minutes followed by a continuous infusion of fenoterol 1µg/min over 120 minutes. The total dose of fenoterol per subject will thus be 145µg.
- Mild cold exposure: During 120 minutes the water temperature in cooling sleeves, covering the participant's waist, is gradually decreased to 10 degrees or to the lowest tolerable temperature without shivering.
干预措施: Fenoterol (Drug)
Normal weight
Experimental
- A bolus of 25µg fenoterol will be slowly injected intravenously during 2-3 minutes followed by a continuous infusion of fenoterol 1µg/min over 120 minutes. The total dose of fenoterol per subject will thus be 145µg.
- Mild cold exposure: During 120 minutes the water temperature in cooling sleeves, covering the participant's waist, is gradually decreased to 10 degrees or to the lowest tolerable temperature without shivering.
干预措施: Mild cold exposure (Other)
Overweight
Experimental
- A bolus of 25µg fenoterol will be slowly injected intravenously during 2-3 minutes followed by a continuous infusion of fenoterol 1µg/min over 120 minutes. The total dose of fenoterol per subject will thus be 145µg.
- Mild cold exposure: During 120 minutes the water temperature in cooling sleeves, covering the participant's waist, is gradually decreased to 10 degrees or to the lowest tolerable temperature without shivering.
干预措施: Fenoterol (Drug)
Overweight
Experimental
- A bolus of 25µg fenoterol will be slowly injected intravenously during 2-3 minutes followed by a continuous infusion of fenoterol 1µg/min over 120 minutes. The total dose of fenoterol per subject will thus be 145µg.
- Mild cold exposure: During 120 minutes the water temperature in cooling sleeves, covering the participant's waist, is gradually decreased to 10 degrees or to the lowest tolerable temperature without shivering.
干预措施: Mild cold exposure (Other)
结局指标
主要结局
BAT SUVmean
时间窗: 30 minutes after end of intervention
18F-FDG uptake into the supra-clavicular brown adipose tissue as determined by 18F-FDG PET-CT after the respective study intervention
次要结局
- BAT SUVmax(30 minutes after intervention)
- BAT glycolytic volume(30 minutes after intervention)
- BAT Volume(30 minutes after intervention)
- Change in energy expenditure(First and last 30 minutes of intervention)
研究者
研究点 (1)
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