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

Primary Purpose

Obesity

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Placebo
Comparator: sibutramine
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Sibutramine

    Placebo

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Intraclass coefficient of correlation of the AvgPSC20 assessed during the fed and fasted conditions over the six ROIs
    Regional cerebral blood flow (rCBF) during the fasted condition with placebo or sibutramine in the six ROIs
    AvgPSC20 in the fed condition with placebo or sibutramine in the six ROIs
    Difference in PSC20 during fasted and fed conditions with placebo or sibutramine in the six ROIs
    rCBF during the fed condition with placebo or sibutramine in the six ROIs
    Difference in rCBF during fasted and fed conditions with placebo or sibutramine in the six ROIs
    Test-retest reliability of rCBF in the six ROIs during the fasted and fed states in men receiving placebo

    Full Information

    First Posted
    June 1, 2009
    Last Updated
    October 9, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00914212
    Brief Title
    A Functional Magnetic Resonance Imaging (fMRI) Study in Overweight and Obese Men (0000-103)
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2009 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    August 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Sibutramine
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Single dose placebo to sibutramine in two of three treatment periods.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: sibutramine
    Other Intervention Name(s)
    sibutramine
    Intervention Description
    Single dose sibutramine 30 mg (2 x 15 mg) in one of three treatment periods.
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    Intraclass coefficient of correlation of the AvgPSC20 assessed during the fed and fasted conditions over the six ROIs
    Time Frame
    Day 1
    Title
    Regional cerebral blood flow (rCBF) during the fasted condition with placebo or sibutramine in the six ROIs
    Time Frame
    Day 1
    Title
    AvgPSC20 in the fed condition with placebo or sibutramine in the six ROIs
    Time Frame
    Day 1
    Title
    Difference in PSC20 during fasted and fed conditions with placebo or sibutramine in the six ROIs
    Time Frame
    Day 1
    Title
    rCBF during the fed condition with placebo or sibutramine in the six ROIs
    Time Frame
    Day 1
    Title
    Difference in rCBF during fasted and fed conditions with placebo or sibutramine in the six ROIs
    Time Frame
    Day 1
    Title
    Test-retest reliability of rCBF in the six ROIs during the fasted and fed states in men receiving placebo
    Time Frame
    Day 1

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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