Obesity, overweight, lipid- and glucose metabolism MedDRA version: 20.0 Level: LLT Classification code 10029885 Term: Obesity, unspecified System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Ventolin infuus/injectie
Pharmaceutical Form: Concentrate for solution for injection/infusion
Trade Name: Propranolol HCl Accord
Pharmaceutical Form: Tablet
Pharmaceutical form of the pla
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the acute effect of ADRB2 activation, via intravenous administration of salbutamol (250 µg), on 18F-FDG uptake by BAT. ;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. - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Resting energy expenditure, as measured by indirect calorimetry - 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) - Lipid pathway analysis using lipidomic analysis in plasma samples - Serum markers for glucose metabolism (glucose, insulin) - Circulating plasma BAT markers (e.g. microRNAs);Timepoint(s) of evaluation of this end point: After completion of the study | — |
Countries
Netherlands
Contacts
Public ContactPrincipal Investigator
Leiden University Medical Center
Outcome results
None listed