Effect of Orlistat in Body Composition

NCT ID: NCT00752726

Last Updated: 2013-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-07-31

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.

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.

Conditions

Obesity; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Orlistat

Orlistat 60 milligram (mg) capsules to be consumed orally with each meal 3 times per day

Group Type: ACTIVE_COMPARATOR

Orlistat

Intervention Type: DRUG

Weight loss treatment

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inactive

Interventions

Orlistat

Weight loss treatment

Intervention Type: DRUG

Placebo

Inactive

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Duke Clinical Research Unit

Durham, North Carolina, United States

Sahlgrenska Academy

Gothenburg, West Gothland, Sweden

Countries

United States; Sweden

References

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.

Reference Type: BACKGROUND

PMID: 21720429 (View on PubMed)

Other Identifiers

W3600586

Identifier Type: -

Identifier Source: org_study_id