Official Title: “The Effect of Xenical on Weight, Risk Factors and Burden of Medication”

The purpose of this study is to determine the effect of using the weight loss medication Xenical (generic name - orlistat) on weight loss and change in heart disease risk factors in patients of the Healthy Heart Program Lipid Clinic at St. Paul's Hospital over a three month period. Xenical works by blocking the body's absorption of dietary fat in the gut, allowing it to pass through to be excreted, therefore reducing the intake of fat and calories. This is a pilot study supported by Hoffmann-La Roche Limited which produces Xenical. The aim is to investigate whether weight loss will also result in reductions in heart disease risk factors that may allow for less of a need for medications controlling lipid levels, hypertension and plasma glucose.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: December 2010

Obesity is associated with numerous chronic diseases and increased cardiovascular mortality.

It is also an independent risk factor for cardiovascular disease (CVD) in addition to being associated with diabetes and CVD risk factors. Weight loss interventions that target body fat reductions are associated with reductions in cholesterol levels, blood pressure and fasting glucose. Xenical (orlistat) is a gastrointestinal lipase inhibitor which results in a reduction in the absorption of exogenous fat. Studies of up to two years duration have demonstrated that those taking Xenical plus diet lost significantly more weight than those taking placebo plus diet. Coincident with this were decreases in cholesterol levels. The use of Xenical in Type 2 diabetic patients being treated with sulfonylurea resulted in greater discontinuation of the sulfonylurea plus a greater reduction in sulfonylurea dosage compared to placebo. The use of Xenical in the clinical environment has the potential to improve CVD risk factors and potentially reduce the burden of other medications.This is a pilot study to investigate the effectiveness of Xenical on cardiovascular risk factors in the patients of St. Paul's Hospital Lipid Clinic.

Intervention(s) in this Clinical Trial

• Drug: Orlistat
  • See Detailed Description.

Primary Measures

• Weight loss
  • Time Frame: three months
    Safety Issue?: No

Secondary Measures

• Lipid profile and insulin, CRP
  • Time Frame: three months
    Safety Issue?: No

Inclusion Criteria:

• 1. Body mass index ≥ 27 with one risk factor for cardiovascular disease OR overweight/obese individuals with type 2 diabetes on standard hypoglycemic agents
• 2. Recently prescribed Xenical at the St. Paul's Hospital Lipid Clinic

Exclusion Criteria:

• 1. Patients with previous experience using Xenical
• 2. Patients currently using other weight loss medications.
• 3. Unable to provide informed consent.
• 4. Less than 19 years of age

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of British Columbia

Overall Clinical Trial Officials and Contacts

Jiri Frohlich, MD Principal Investigator University of British Columbia  

Overall Contact: Luba Cermakova 604-682-2344 

Information obtained from ClinicalTrials.gov on November 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00152360

Study ID Number: P03-0151

ClinicalTrials.gov Identifier: NCT00152360

Health Authority: Canada: Health Canada