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

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: Placebo

• Registration Number: NCT00914212
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-09
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Test-retest reliability of rCBF in the six ROIs during the fasted and fed states in men receiving placebo	Day 1
Difference in PSC20 during fasted and fed conditions 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
Intraclass coefficient of correlation of the AvgPSC20 assessed during the fed and fasted conditions over the six ROIs	Day 1
AvgPSC20 in the fed condition 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
rCBF during the fed condition with placebo or sibutramine in the six ROIs	Day 1