Effect of Orlistat in Body Composition

Obesity Clinical Trial

Official title:

The Effects of Weight Reduction With Orlistat vs. Placebo on Changes in Body Composition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00752726
• Other study ID #: W3600586
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2008
• Last updated: February 28, 2013
• Start date: September 2008
• Est. completion date: July 2009

Study information

• Verified date: February 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Orlistat
Weight loss treatment
• Placebo
Inactive

Locations

Country	Name	City	State
Sweden	Sahlgrenska Academy	Goteborg	West Gothland
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Duke Clinical Research Unit	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 24 in Abdominal VAT Mass	VAT was measured by the computed tomography (CT) scan.	Baseline to week 24	No
Secondary	Change From Baseline to Week 12 in Abdominal VAT Mass	Abdominal VAT mass from baseline to week 12 was measured by CT scan.	Baseline to week 12	No
Secondary	Change From Baseline to Week 24 in Body Weight	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.	Baseline to week 24	No
Secondary	Change From Baseline to Week 24 in Total Fat Mass	Change in total fat mass was calculated from an average of three measurements at each visit from Echo Magnetic Resonance Imaging (EchoMRI).	Baseline to week 24	No
Secondary	Change From Baseline to Week 24 in Percentage Body Fat	Body fat was assessed through Bioelectrical Impedance Analysis (BIA).	Baseline to week 24	No
Secondary	Change From Baseline to Week 24 in Waist Circumference	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.	Baseline to week 24	No
Secondary	Change From Baseline to Week 24 in Percentage Liver Fat	For Liver fat, Intrahepatic lipids (IHL) were measured by Magnetic Resonance Spectroscopy (MRS).	Baseline to week 24	No
Secondary	Change From Baseline to Week 24 in Liver Fat	The liver fat was measured by CT scan in Hounsfield Units (HU).	Baseline to week 24	No
Secondary	Change From Baseline to Week 24 in Total Calories Expended for Physical Activity	Measurement of physical activity from Paffenbarger questionnaire. The number of caloried expended was representation of activity level: Higher calorie counts indicate higher activity	Baseline to week 24	No
Secondary	Change From Baseline to Week 24 in Quality of Life (QoL) Scores.	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.	Baseline to week 24	No
Secondary	Selectivity Index at 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.	Baseline to week 24	No