Obesity and dyslipidemia
Conditions
Interventions
Trade Name: Betmiga
Product Name: Mirabegron
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Male volunteers. 10 white Caucasians, born in the Netherlands. 10 South Asians, living in the Netherlands. • Age: 18-30 years • BMI = 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • BMI > 25 kg/m2 • Recent excessive weight loss or exercise • Alcohol and/ or drugs abuse • Excessieve smoking (>10 cigarettes/day) • Any significant chronic disease, including diabetes, Renal, hepatic or endocrine disease • Heart disease or arrhythmias • Thyroid disease or thyroid medication • Hypertension • Use of medication known to influence glucose and/or lipid metabolism or BAT activity (e.g. beta blockers or calcium channel blockers) • Use of drugs that influence cardiac function or affect QT time • Use of MAO inhibitor • Use of systemic corticosteroids in previous six weeks • Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year • Contraindications for undergoing an MRI scan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of Mirabegron treatment on brown fat activity measured by MRI in South Asians compared with white Caucasians.;Secondary Objective: The secondary objecties of the study are to assess: 1. differences in the effect of Mirabegron treatment on a) resting energy expenditure, b) plasma lipid levels c) and sympathetic output between South Asian and white Caucasian individuals. 2. differences between indirect BAT activation by cold exposure and direct BAT activation with Mirabegron treatment. 3. MRI scan as novel way to visualize BAT activity 4. the effect of mild cold exposure and Mirabegron on plasma lipoprotein profiles ;Primary end point(s): - BAT activity measured by MRI scan;Timepoint(s) of evaluation of this end point: 3 hours after either mild cold exposure, administration of Mirabgeron or a placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Fasted REE by indirect calorimetry - Change in supraclavicular skin temperature (as measured with iButtons) - Fasting serum markers for lipid metabolism (total cholesterol, HDL-C, LDL-C, triglycerides, free fatty acids) and dynamic changes in lipoproteins. - Fasting serum markers for sympathetic output (norepinephrine, epinephrine) ;Timepoint(s) of evaluation of this end point: 3 hours after either mild cold exposure, administration of Mirabgeron or a placebo. | — |
Countries
Netherlands
Contacts
Public ContactClinical trial information
Leiden University Medical Center
Outcome results
None listed