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| Sponsor: | University of British Columbia |
|---|---|
| Information provided by (Responsible Party): | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00152360 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Heart Diseases |
Drug: Orlistat |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effect of Xenical on Weight, Risk Factors and Burden of Medication |
| Estimated Enrollment: | 25 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Luba Cermakova | 604-682-2344 ext 63139 |
| Canada, British Columbia | |
| Healthy Heart Program/Lipid Clinic, St. Paul's Hospital | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Luba Cermakova 604-682-2344 ext 63139 | |
| Principal Investigator: | Jiri Frohlich, MD | University of British Columbia |
More Information
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00152360 History of Changes |
| Other Study ID Numbers: | P03-0151 |
| Study First Received: | September 7, 2005 |
| Last Updated: | February 6, 2012 |
| Health Authority: | Canada: Health Canada |
|
Obesity weight loss cardiovascular risk factors Obesity and obesity related pathology |
|
Heart Diseases Obesity Cardiovascular Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
Orlistat Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Obesity Agents Central Nervous System Agents Therapeutic Uses |
