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

Merck Sharp & Dohme LLC15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Obesity

Interventions

PlaceboDRUG

Single dose placebo to sibutramine in two of three treatment periods.

Comparator: sibutramineDRUG

Single dose sibutramine 30 mg (2 x 15 mg) in one of three treatment periods.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Average percent signal change of the top 20% of activated voxels (AvgPSC20) during the fasted condition over six primary brain regions of interest (ROI)

Time frame: Day 1

Secondary Outcomes

Intraclass coefficient of correlation of the AvgPSC20 assessed during the fed and fasted conditions over the six ROIs

Time frame: Day 1

Regional cerebral blood flow (rCBF) during the fasted condition with placebo or sibutramine in the six ROIs

Time frame: Day 1

AvgPSC20 in the fed condition with placebo or sibutramine in the six ROIs

Time frame: Day 1

Difference in PSC20 during fasted and fed conditions with placebo or sibutramine in the six ROIs

Time frame: Day 1

rCBF during the fed condition with placebo or sibutramine in the six ROIs

Time frame: Day 1

Difference in rCBF during fasted and fed conditions with placebo or sibutramine in the six ROIs

Time frame: Day 1

Test-retest reliability of rCBF in the six ROIs during the fasted and fed states in men receiving placebo

Time frame: Day 1

Data from ClinicalTrials.gov

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