Effect of Orlistat in Body Composition

• Change From Baseline to Week 24 in Abdominal VAT Mass [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
  VAT was measured by the computed tomography (CT) scan.
  
  

• Change From Baseline to Week 12 in Abdominal VAT Mass [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  Abdominal VAT mass from baseline to week 12 was measured by CT scan.
  
  
• Change From Baseline to Week 24 in Body Weight [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
  Participants were weighed at least twice until two consecutive measurements were within 0.5 kg of each other and the average of the two measurements was recorded.
  
  
• Change From Baseline to Week 24 in Total Fat Mass [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
  Change in total fat mass was calculated from an average of three measurements at each visit from Echo Magnetic Resonance Imaging (EchoMRI).
  
  
• Change From Baseline to Week 24 in Percentage Body Fat [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
  Body fat was assessed through Bioelectrical Impedance Analysis (BIA).
  
  
• Change From Baseline to Week 24 in Waist Circumference [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
  Waist circumference was measured against the skin, without interference from clothing, at the level midway between the lateral lower rib margin and the iliac crest in standing position.
  
  
• Change From Baseline to Week 24 in Percentage Liver Fat [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
  For Liver fat, Intrahepatic lipids (IHL) were measured by Magnetic Resonance Spectroscopy (MRS).
  
  
• Change From Baseline to Week 24 in Liver Fat [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
  The liver fat was measured by CT scan in Hounsfield Units (HU).
  
  
• Change From Baseline to Week 24 in Total Calories Expended for Physical Activity [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
  Measurement of physical activity from Paffenbarger questionnaire. The number of caloried expended was representation of activity level: Higher calorie counts indicate higher activity
  
  
• Change From Baseline to Week 24 in Quality of Life (QoL) Scores. [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
  QoL scores were measured using an Impact of Weight Quality of Life (IWQoL) Questionnaire, which scored the responses at a scale of 1 to 5(1, never true, to 5, always true): QoL scales for physical function, self-esteem, sexual life, public distress, and work were evaluated, and summarized in a total score. A higher value indicated a better quality of life.
  
  
• Selectivity Index at Week 24 [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
  The selectivity index (SI) was used as a measure of orlistat's ability to target abdominal VAT loss compared to total adipose tissue lost. SI was calculated using the following equation: Mean % change in VAT divided by Mean % change in total fat mass.
  
  

Large amounts of VAT (adipose tissue surrounding the viscera of the organs), is known to be associated with increased risk of heart disease and diabetes. Orlistat (tetrahydrolipstatin or THL) inhibits gastrointestinal lipase and reduces the absorption of dietary fat. The purpose of this study is to to determine if a 24 week weight loss program with orlistat 60 mg would produce greater changes in adipose tissue depots (specifically VAT) compared to placebo. This study will use the Echo MRI technology across multiple sites to measure total fat mass. EchoMRI is a non invasive method ideally suited for studies which track changes in human body composition over time, with measuring times of less than 3 minutes and no radiation exposure.