The Effect of Xenical on Weight and Risk Factors
Information source: University of British Columbia
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity; Heart Diseases
Intervention: Orlistat (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s):
Jiri Frohlich, MD, Principal Investigator, Affiliation: University of British Columbia
Overall contact:
Luba Cermakova, Phone: 604-682-2344, Ext: 63139
Summary
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.
Clinical Details
Official title: The Effect of Xenical on Weight, Risk Factors and Burden of Medication
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Primary outcome: Weight loss
Secondary outcome: Lipid profile and insulin, CRP
Detailed description:
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.
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Luba Cermakova, Phone: 604-682-2344, Ext: 63139
Healthy Heart Program/Lipid Clinic, St. Paul’s Hospital, Vancouver, British Columbia, Canada; Recruiting
Luba Cermakova, Phone: 604-682-2344, Ext: 63139
Additional Information
Starting date: June 2005
Ending date: May 2006
Last updated: July 18, 2007
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