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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00914212
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE June 1, 2009
First Posted Date  ICMJE June 4, 2009
Last Update Posted Date October 12, 2015
Study Start Date  ICMJE May 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Functional Magnetic Resonance Imaging (fMRI) Study in Overweight and Obese Men (0000-103)
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: Placebo
    Single dose placebo to sibutramine in two of three treatment periods.
  • Drug: Comparator: sibutramine
    Single dose sibutramine 30 mg (2 x 15 mg) in one of three treatment periods.
    Other Name: sibutramine
Study Arms  ICMJE
  • Active Comparator: 1
    Sibutramine
    Intervention: Drug: Comparator: sibutramine
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2009)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Belgium
 
Administrative Information
NCT Number  ICMJE NCT00914212
Other Study ID Numbers  ICMJE 0000-103
103
2009_597
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP