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Trial record 10 of 69 for:    ORLISTAT

Effect of Orlistat in Body Composition

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ClinicalTrials.gov Identifier: NCT00752726
Recruitment Status : Completed
First Posted : September 15, 2008
Results First Posted : February 7, 2013
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to determine if a 24 week weight loss program with orlistat 60 mg will produce greater changes in body composition compared to placebo.

Condition or disease Intervention/treatment Phase
Obesity Overweight Drug: Orlistat Drug: Placebo Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Weight Reduction With Orlistat vs. Placebo on Changes in Body Composition
Study Start Date : September 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control
Drug Information available for: Orlistat

Arm Intervention/treatment
Active Comparator: Orlistat
Orlistat 60 milligram (mg) capsules to be consumed orally with each meal 3 times per day
Drug: Orlistat
Weight loss treatment

Placebo Comparator: Placebo
Placebo to match Orlistat 60 mg capsules to be consumed orally with each meal 3 times per day.
Drug: Placebo
Inactive




Primary Outcome Measures :
  1. Change From Baseline to Week 24 in Abdominal VAT Mass [ Time Frame: Baseline to week 24 ]
    VAT was measured by the computed tomography (CT) scan.


Secondary Outcome Measures :
  1. Change From Baseline to Week 12 in Abdominal VAT Mass [ Time Frame: Baseline to week 12 ]
    Abdominal VAT mass from baseline to week 12 was measured by CT scan.

  2. Change From Baseline to Week 24 in Body Weight [ Time Frame: Baseline to week 24 ]
    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.

  3. Change From Baseline to Week 24 in Total Fat Mass [ Time Frame: Baseline to week 24 ]
    Change in total fat mass was calculated from an average of three measurements at each visit from Echo Magnetic Resonance Imaging (EchoMRI).

  4. Change From Baseline to Week 24 in Percentage Body Fat [ Time Frame: Baseline to week 24 ]
    Body fat was assessed through Bioelectrical Impedance Analysis (BIA).

  5. Change From Baseline to Week 24 in Waist Circumference [ Time Frame: Baseline to week 24 ]
    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.

  6. Change From Baseline to Week 24 in Percentage Liver Fat [ Time Frame: Baseline to week 24 ]
    For Liver fat, Intrahepatic lipids (IHL) were measured by Magnetic Resonance Spectroscopy (MRS).

  7. Change From Baseline to Week 24 in Liver Fat [ Time Frame: Baseline to week 24 ]
    The liver fat was measured by CT scan in Hounsfield Units (HU).

  8. Change From Baseline to Week 24 in Total Calories Expended for Physical Activity [ Time Frame: Baseline to week 24 ]
    Measurement of physical activity from Paffenbarger questionnaire. The number of caloried expended was representation of activity level: Higher calorie counts indicate higher activity

  9. Change From Baseline to Week 24 in Quality of Life (QoL) Scores. [ Time Frame: Baseline to week 24 ]
    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.

  10. Selectivity Index at Week 24 [ Time Frame: Baseline to week 24 ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18-60 years inclusive
  • Body Mass Index (BMI): BMI in the range of 25.0-34.9 kg/m^2
  • Waist circumference:

Females: > 35 inches Males: > 40 inches

  • Diet:

    1. Normal eating habits, consuming 3 meals a day (breakfast, lunch and dinner)
    2. Willing to follow a hypocaloric diet during the study to achieve weight loss
    3. Willing to take a daily multivitamin for the duration of the study.
  • General Health:Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination

Exclusion Criteria:

  • Pregnant and/ or Breast-feeding women
  • Diet/Exercise:Currently on a special diet or who cannot fulfill the dietary requirements of the study.
  • Smoking History:a) Smoking cessation within the past 6 months b) Current Smokers
  • Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials and study foods (or closely related compounds) or any of their stated ingredients.
  • Medication:

    a) Currently taking medication for weight loss or appetite control. b) Previous Xenical® (orlistat) or alli® use within 3 months of screening date c) Currently taking medication or supplements that influence intestinal transit time and other stool formation parameters or influences cramping (e.g., Anticholinergics (such as atropine) or cholinergics (such as physostigmine), phenothiazines, tricyclic antidepressants, opioid analgesics (including loperamide), calcium channel antagonists, clonidine, cisapride, octreotide. Also, any laxative or antidiarrheal product). d) Currently taking or withdrawn during the past 6 months any drugs with significant impact on body weight (e.g. serotoninergically acting drugs, antidepressants, central adrenergically acting drugs, drugs inhibiting digestion and absorption, appetite suppressants, metformin) e) Currently taking Cyclosporine, Warfarin or Amiodarone HCL

  • Disease/Surgery:

    a) History of gastrointestinal disease (e.g., irritable bowel syndrome, diarrhea, inflamed bowel, steatorrhea/fat malabsorption, hemorrhoids, incontinence, pancreatitis). b) History of psychological disorder, including eating disorders such as anorexia nervosa and bulimia c) History of neurological disorder (e.g. seizures, parkinson's disease, Alzheimer's disease) d) History of hypo/hyperthyroidism unless euthyroid and controlled on a stable dose of medication for at least 6 months. e) History of surgery for weight loss f) Uncontrolled hypertension g) Heart Disease h) Diabetes Mellitus (Type 1 and 2) (Fasting Blood Glucose >126 mg/dL)

  • Participant has a known history of panic attacks and/or claustrophobia or other conditions precluding safe EchoMRI, CT or other scanning modalities according to local guidelines, (e.g., pacemaker, hearing aid, metallic body piercing and/or other metal implants) or in the opinion of the Investigator the participant exceeds size limitations for the instruments.
  • Participant has had a weight loss or gain of greater than or equal to 3 kg in the 3 months prior to screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752726


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
United States, North Carolina
Duke Clinical Research Unit
Durham, North Carolina, United States, 27710
Sweden
Sahlgrenska Academy
Goteborg, West Gothland, Sweden, 405 30
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00752726     History of Changes
Other Study ID Numbers: W3600586
First Posted: September 15, 2008    Key Record Dates
Results First Posted: February 7, 2013
Last Update Posted: March 8, 2013
Last Verified: February 2013
Keywords provided by GlaxoSmithKline:
overweight, orlistat, body composition
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Lipid Regulating Agents