A Functional Magnetic Resonance Imaging (fMRI) Study in Overweight and Obese Men (0000-103)

Study Overview
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Brief Summary
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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.

Official Title
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A Functional Magnetic Resonance Imaging (fMRI) Study of the Reproducibility and the Effect of Sibutramine During Fasted and Fed Conditions in Healthy Overweight and Obese Men

Conditions
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Obesity

Intervention / Treatment
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* Drug: Placebo
* Drug: Comparator: sibutramine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Sibutramine | Drug: Comparator: sibutramine<br>* Single dose sibutramine 30 mg (2 x 15 mg) in one of three treatment periods.<br>* Other names: sibutramine;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Single dose placebo to sibutramine in two of three treatment periods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraclass coefficient of correlation of the AvgPSC20 assessed during the fed and fasted conditions over the six ROIs |  | Day 1 | 
| Regional cerebral blood flow (rCBF) during the fasted 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 | 
| rCBF during the fed condition with placebo or sibutramine in the six ROIs |  | Day 1 | 
| 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 |