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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-08-31

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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Sibutramine

Group Type ACTIVE_COMPARATOR

Comparator: sibutramine

Intervention Type DRUG

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

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

Comparator: sibutramine

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

Intervention Type DRUG

Other Intervention Names

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sibutramine

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes