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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Comparator: sibutramine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2; Placebo	Drug: Placebo; Single dose placebo to sibutramine in two of three treatment periods.
ACTIVE_COMPARATOR: 1; Sibutramine	Drug: Comparator: sibutramine; Single dose sibutramine 30 mg (2 x 15 mg) in one of three treatment periods.; Other Names: sibutramine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Difference in rCBF during fasted and fed conditions with placebo or sibutramine in the six ROIs	Day 1
Test-retest reliability of rCBF in the six ROIs during the fasted and fed states in men receiving placebo	Day 1

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ACTUAL): August 1, 2009
• Study Completion (ACTUAL): August 1, 2009

Study Registration Dates

• First Submitted: June 1, 2009
• First Submitted That Met QC Criteria: June 3, 2009
• First Posted (ESTIMATE): June 4, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 12, 2015
• Last Update Submitted That Met QC Criteria: October 9, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight; Psychotropic Drugs; Antidepressive Agents; Appetite Depressants; Anti-Obesity Agents; Sibutramine
• Other Study ID Numbers: 0000-103; 103; 2009_597