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Completed

NCT Number: NCT00914212

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Single dose placebo to sibutramine in two of three treatment periods.

Comparator: sibutramine

Drug

Single dose sibutramine 30 mg (2 x 15 mg) in one of three treatment periods.

Other names: sibutramine

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)

    Time frame: Day 1

Secondary outcomes

  1. Intraclass coefficient of correlation of the AvgPSC20 assessed during the fed and fasted conditions over the six ROIs

    Time frame: Day 1

  2. Regional cerebral blood flow (rCBF) during the fasted condition with placebo or sibutramine in the six ROIs

    Time frame: Day 1

  3. AvgPSC20 in the fed condition with placebo or sibutramine in the six ROIs

    Time frame: Day 1

  4. Difference in PSC20 during fasted and fed conditions with placebo or sibutramine in the six ROIs

    Time frame: Day 1

  5. rCBF during the fed condition with placebo or sibutramine in the six ROIs

    Time frame: Day 1

  6. Difference in rCBF during fasted and fed conditions with placebo or sibutramine in the six ROIs

    Time frame: Day 1

  7. Test-retest reliability of rCBF in the six ROIs during the fasted and fed states in men receiving placebo

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 4, 2009
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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