Activation of human brown adipose tissue with the use of salbutamol
- Conditions
- MedDRA version: 20.0Level: LLTClassification code 10029885Term: Obesity, unspecifiedSystem Organ Class: 100000004861Obesity, overweight, lipid- and glucose metabolismTherapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2020-004059-34-NL
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 10
- Dutch white Caucasian males
- Age between 18-35 years old
- Lean (BMI = 18 and = 25 kg/m2)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Diabetes mellitus (determined on basis of fasting glucose levels defined by ADA criteria)
- Any other active endocrine disease (thyroid disease, any signs of Cushing’s syndrome, adrenal disease and lipid-associated disorders such as familial hypercholesterolemia)
- Any cardiac disease (i.e. ischemic cardiac disease, arrhythmias, severe heart failure)
- A first-degree family member with sudden cardiac death
- Any chronic renal or hepatic disease
- Use of beta-adrenergic receptor agonists (for e.g. asthma)
- Use of medication known to influence glucose and/or lipid metabolism or brown fat activity (e.g. beta-blockers, antidepressants, corticosteroids)
- Use of medication shown to increase risk on hypokalemia after salbutamol administration (e.g. xanthine derivatives, steroids and diuretics)
- Any other contra-indications for the use of salbutamol or propranolol
- Abuse of alcohol or other substances
- Smoking
- Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study
- Current participation in another research projects that may influence the current research project
- Participation in another research in which a PET-CT scan was performed within a year before the start of the current study
- Clinically relevant abnormalities in clinical chemistry or electrocardiogram (ECG) at screening (to be judged by the study physician)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the acute effect of ADRB2 activation, via intravenous administration of salbutamol (250 µg), on 18F-FDG uptake by BAT.<br>;Primary end point(s): - Glucose uptake by BAT, as measured by dynamic 18F-FDG PET/CT acquisition;Timepoint(s) of evaluation of this end point: After completion of the study ;Secondary Objective: - To assess the acute effect of ADRB2 activation via intravenous administration of salbutamol (250 µg) on resting energy expenditure, serum markers for lipid- and glucose metabolism and plasma BAT markers.<br>- To confirm that the stimulatory effect of salbutamol on 18F-FDG uptake by BAT is not mediated via the ADRB3, by showing that the acute effect of i.v. salbutamol (250 µg) on BAT is blunted by co-administration of the ADRB1/2-blocker propranolol.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Resting energy expenditure, as measured by indirect calorimetry<br>- Serum markers for lipid metabolism (triglycerides (TG), total cholesterol (TC), high density lipoprotein-cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), free fatty acids)<br>- Lipid pathway analysis using lipidomic analysis in plasma samples<br>- Serum markers for glucose metabolism (glucose, insulin)<br>- Circulating plasma BAT markers (e.g. microRNAs);Timepoint(s) of evaluation of this end point: After completion of the study