Beta 2 Adrenergic Stimulation vs Cold Exposure to Activate Human Brown Adipose Tissue

EKNZ 2022-00037

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.

2022-04-27

2023-03-06

2023-03-06

Completed

Early phase I

12

Inclusion Criteria: * BMI 18,5-23 kg/m2 or 30-35 kg/m2 Exclusion Criteria: * 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)

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Open-label, cross-over trial in healthy volunteers with random sequence of the two study interventions', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}

2023-09-26