Obesity
Conditions
Brief summary
This study will determine whether BOLD-fMRI can be used to probe hunger and satiety states in healthy overweight or obese men and also whether fasted/fed fMRI signals can be modulated by sibutramine.
Interventions
DRUGPlacebo
Single dose placebo to sibutramine in two of three treatment periods.
DRUGComparator: sibutramine
Single dose sibutramine 30 mg (2 x 15 mg) in one of three treatment periods.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is a male between 18 and 45 years of age * Subject has a body mass index (BMI) between 28 and 35 kg/m\^2 * Subject does not weigh more than 140 kg (309 lbs) at the screening visit * Subject is right-handed * Subject is a non-smoker * Subject is in generally good health * Subject has normal or corrected to normal vision
Exclusion criteria
* Subject works a night shift within 3 days of each treatment visit * Subject has permanent cosmetic or metallic objects in his body * Subject has attention deficit hyperactivity disorder (ADHD) * Subject has or had sleep apnea * Subject has a history of neurological disorders * Subject has a history of any clinically significant disease or condition * Subject is vegan or vegetarian * Subject has a history of eating disorders * Subject has had previous bariatric surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average percent signal change of the top 20% of activated voxels (AvgPSC20) during the fasted condition over six primary brain regions of interest (ROI) | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Difference in rCBF during fasted and fed conditions with placebo or sibutramine in the six ROIs | Day 1 |
| Test-retest reliability of rCBF in the six ROIs during the fasted and fed states in men receiving placebo | Day 1 |
| Intraclass coefficient of correlation of the AvgPSC20 assessed during the fed and fasted conditions over the six ROIs | Day 1 |
| rCBF during the fed condition with placebo or sibutramine in the six ROIs | Day 1 |
| AvgPSC20 in the fed condition with placebo or sibutramine in the six ROIs | Day 1 |
| Difference in PSC20 during fasted and fed conditions with placebo or sibutramine in the six ROIs | Day 1 |
| Regional cerebral blood flow (rCBF) during the fasted condition with placebo or sibutramine in the six ROIs | Day 1 |
Outcome results
None listed