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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: June 1, 2009
Last updated: October 9, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Drug: Placebo
Drug: Comparator: sibutramine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

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) [ Time Frame: Day 1 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: May 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Drug: Comparator: sibutramine
Single dose sibutramine 30 mg (2 x 15 mg) in one of three treatment periods.
Other Name: sibutramine
Placebo Comparator: 2
Drug: Placebo
Single dose placebo to sibutramine in two of three treatment periods.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00914212

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00914212     History of Changes
Other Study ID Numbers: 0000-103
Study First Received: June 1, 2009
Last Updated: October 9, 2015

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Antidepressive Agents
Psychotropic Drugs
Appetite Depressants
Anti-Obesity Agents processed this record on May 23, 2017