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Trial record 24 of 69 for:    ORLISTAT

The Effect of Xenical on Weight and Risk Factors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00152360
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : April 1, 2013
Information provided by (Responsible Party):
University of British Columbia

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Heart Diseases Drug: Orlistat Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Xenical on Weight, Risk Factors and Burden of Medication
Study Start Date : June 2005
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Orlistat

Arm Intervention/treatment
Experimental: Xenical (Orlistat)
Investigating the effectiveness of Xenical on cardiovascular risk factors in the patients of St. Paul's Hospital Lipid Clinic
Drug: Orlistat
See Detailed Description.

Primary Outcome Measures :
  1. Weight loss [ Time Frame: three months ]

Secondary Outcome Measures :
  1. Lipid profile and insulin, CRP [ Time Frame: three months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00152360

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Canada, British Columbia
Healthy Heart Program/Lipid Clinic, St. Paul's Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Jiri Frohlich, MD University of British Columbia

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Responsible Party: University of British Columbia Identifier: NCT00152360     History of Changes
Other Study ID Numbers: P03-0151
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: April 1, 2013
Last Verified: March 2013
Keywords provided by University of British Columbia:
weight loss
cardiovascular risk factors
Obesity and obesity related pathology
Additional relevant MeSH terms:
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Heart Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms
Cardiovascular Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Lipid Regulating Agents