A Functional Magnetic Resonance Imaging (fMRI) Study in Overweight and Obese Men (0000-103)
3 other identifiers
interventional
15
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 obesity
Started May 2009
Shorter than P25 for phase_1 obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 1, 2009
CompletedFirst Posted
Study publicly available on registry
June 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedOctober 12, 2015
October 1, 2015
3 months
June 1, 2009
October 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Average percent signal change of the top 20% of activated voxels (AvgPSC20) during the fasted condition over six primary brain regions of interest (ROI)
Day 1
Secondary Outcomes (7)
Intraclass coefficient of correlation of the AvgPSC20 assessed during the fed and fasted conditions over the six ROIs
Day 1
Regional cerebral blood flow (rCBF) during the fasted condition with placebo or sibutramine in the six ROIs
Day 1
AvgPSC20 in the fed condition with placebo or sibutramine in the six ROIs
Day 1
Difference in PSC20 during fasted and fed conditions with placebo or sibutramine in the six ROIs
Day 1
rCBF during the fed condition with placebo or sibutramine in the six ROIs
Day 1
- +2 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORSibutramine
2
PLACEBO COMPARATORPlacebo
Interventions
Single dose sibutramine 30 mg (2 x 15 mg) in one of three treatment periods.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2009
First Posted
June 4, 2009
Study Start
May 1, 2009
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
October 12, 2015
Record last verified: 2015-10