Last updated: 11/04/2018 13:43:14
Effect of Orlistat in Body Composition
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: The effects of weight reduction with orlistat vs. placebo on changes in body composition
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from baseline to week 24 in abdominal VAT mass
Timeframe: Baseline to week 24
Secondary outcomes:
Change from baseline to week 12 in abdominal VAT mass
Timeframe: Baseline to week 12
Change from baseline to week 24 in Body weight
Timeframe: Baseline to week 24
Change from baseline to week 24 in Total Fat Mass
Timeframe: Baseline to week 24
Change from baseline to week 24 in Percentage Body Fat
Timeframe: Baseline to week 24
Change from baseline to week 24 in Waist Circumference
Timeframe: Baseline to week 24
Change from baseline to week 24 in Percentage Liver Fat
Timeframe: Baseline to week 24
Change from baseline to week 24 in Liver Fat
Timeframe: Baseline to week 24
Change from baseline to week 24 in Total Calories Expended for Physical Activity
Timeframe: Baseline to week 24
Change from baseline to week 24 in Quality of Life (QoL) scores.
Timeframe: Baseline to week 24
Selectivity Index at week 24
Timeframe: Baseline to week 24
Interventions:
Drug: Orlistat
Drug: Placebo
Enrollment:
131
Observational study model:
Not applicable
Primary completion date:
2009-31-07
Time perspective:
Not applicable
Clinical publications:
Smith SR, Stenlof KS, Greenway FL, McHutchison J, Schwartz SM, Dev VB, Berk ES, Kapikian R. Orlistat 60 mg reduces visceral adipose tissue: a 24-week randomized, placebo-controlled, multicenter trial. Obesity (Silver Spring). 2011 Sep;19(9):1796-803. doi: 10.1038/oby.2011.143. Epub 2011 Jun 30.
Smith SR, Stenlof KS, Greenway FL, McHutchison J, Schwartz SM, Dev VB, Berk ES, Kapikian R. Orlistat 60 mg reduces visceral adipose tissue: a 24-week randomized, placebo-controlled, multicenter trial. Obesity (Silver Spring). 2011 Sep;19(9):1796-803. doi: 10.1038/oby.2011.143. Epub 2011 Jun 30.
Medical condition
Obesity, Overweight
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2008 to July 2009
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
- Aged 18-60 years inclusive
- Body Mass Index (BMI): BMI in the range of 25.0-34.9 kg/m^2
- Pregnant and/ or Breast-feeding women
- Diet/Exercise:Currently on a special diet or who cannot fulfill the dietary requirements of the study.
Inclusion and exclusion 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: a) Normal eating habits, consuming 3 meals a day (breakfast, lunch and dinner) b) Willing to follow a hypocaloric diet during the study to achieve weight loss c) 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.
Trial location(s)
Location
Pennington Biomedical Research Center
Baton Rouge, LA, United States, 70808
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-31-07
Actual study completion date
2009-31-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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