No registrations found.
ID
Source
Brief title
Health condition
Obesity, cardiovascular diseases
Sponsors and support
Intervention
Outcome measures
Primary outcome
Glucose uptake by BAT, as measured by dynamic [18F]FDG PET/CT acquisition
Secondary outcome
- 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)
Background summary
The study is a randomized double-blinded cross-over trial, that will be carried out at the Leiden University Medical Center (LUMC). This trial encompasses one screening and two study days. This study will be carried out in 10 healthy white Caucasian males between 18 and 35 years old. For all subjects on both study days the intervention consists of intravenous (IV) injection of salbutamol. This will be combined with either placebo (day 1 or 2) or propranolol (day 1 or 2) oral capsules, which will be given 60 minutes prior to salbutamol injection. In addition, to visualize supraclavicular BAT all subjects will undergo a dynamic [18F]FDG PET/CT scan on both study days. The primary outcome is glucose uptake by BAT, as measured by dynamic [18F]FDG PET/CT acquisition. Other endpoints are resting energy expenditure, serum markers for lipid- and glucose metabolism, lipidomics and circulating batokines.
Study objective
We hypothesize that sympathetic activation of human BAT is mainly mediated by the ADRB2 rather than the ADRB3
Study design
0 and 1 week (cross-over)
Intervention
For all subjects on both study days the intervention consists of intravenous (IV) injection of salbutamol. This will be combined with either placebo (day 1 or 2) or propranolol (day 1 or 2) oral capsules, which will be given 60 minutes prior to salbutamol injection. In addition, to visualize supraclavicular BAT all subjects will undergo a dynamic [18F]FDG PET/CT scan on both study days.
Inclusion criteria
- Dutch white Caucasian males
- Age between 18-35 years old
- Lean (BMI ≥ 18 and ≤ 25 kg/m2)
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 with exposure to radiation burden 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9345 |
| Other | METC-LDD : P20-113 |