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 intake of fat and calories. This is a pilot study supported by Hoffmann-La Roche Limited which produces Xenical and the aim is to investigate whether weight loss will also result in reductions in heart disease risk factors that may allow for less need for medications controlling their lipid levels, hypertension and plasma glucose

Condition	Intervention	Phase
Obesity and obesity related pathology	Drug: Orlistat	Phase IV

Further Study Details: 

Primary Outcomes: Weight loss ( three months )
Secondary Outcomes: Lipid profile and Insulin, CRP ( three months)
Expected Total Enrollment:  25

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 gastro-intestinal 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.

Ages Eligible for Study:  19 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

1. Body mass index ≥27 with one risk factor for cardiovascular disease OR
2. Overweight/obese individuals with Type 2 diabetes on standard hypoglycemic agents
3. 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00152360

Luba Cermakova      604 682 2344  Ext. 63139 

Canada, British Columbia
      Healthy Heart Program / Lipid Clinic, St. Paul’s Hospital, Vancouver,  British Columbia,  Canada; Recruiting

Study chairs or principal investigators

Jiri Frohlich, MD,  Principal Investigator,  University of British Columbia   

Study ID Numbers:  P03-0151
Last Updated:  September 8, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00152360
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13