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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00914212
First received: June 1, 2009
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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
Obesity
Drug: Placebo
Drug: Comparator: sibutramine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Regional cerebral blood flow (rCBF) during the fasted condition with placebo or sibutramine in the six ROIs [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • AvgPSC20 in the fed condition with placebo or sibutramine in the six ROIs [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Difference in PSC20 during fasted and fed conditions with placebo or sibutramine in the six ROIs [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • rCBF during the fed condition with placebo or sibutramine in the six ROIs [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Difference in rCBF during fasted and fed conditions with placebo or sibutramine in the six ROIs [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Test-retest reliability of rCBF in the six ROIs during the fasted and fed states in men receiving placebo [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914212

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00914212     History of Changes
Other Study ID Numbers: 0000-103, 103, 2009_597
Study First Received: June 1, 2009
Last Updated: May 9, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Sibutramine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents

ClinicalTrials.gov processed this record on August 01, 2014