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The Effect of Xenical on Weight and Risk Factors

This study is currently recruiting participants.
Verified by University of British Columbia, September 2008

Sponsored by: University of British Columbia
Information provided by: 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

MedlinePlus related topics:   Heart Diseases    Obesity    Weight Control   

Drug Information available for:   Orlistat   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:   The Effect of Xenical on Weight, Risk Factors and Burden of Medication

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Weight loss [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipid profile and insulin, CRP [ Time Frame: three months ] [ Designated as safety issue: No ]

Estimated Enrollment:   25
Study Start Date:   June 2005
Estimated Study Completion Date:   December 2010
Estimated Primary Completion Date:   December 2010 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: Orlistat
    See Detailed Description.
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
Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152360

Contacts
Contact: Luba Cermakova     604-682-2344 ext 63139    

Locations
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        

Sponsors and Collaborators
University of British Columbia

Investigators
Principal Investigator:     Jiri Frohlich, MD     University of British Columbia    
  More Information


Responsible Party:   University of British Columbia ( Dr. Jiri Frohlich )
Study ID Numbers:   P03-0151
First Received:   September 7, 2005
Last Updated:   September 24, 2008
ClinicalTrials.gov Identifier:   NCT00152360
Health Authority:   Canada: Health Canada

Keywords provided by University of British Columbia:
Obesity  
weight loss  
cardiovascular risk factors  
Obesity and obesity related pathology  

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Orlistat
Heart Diseases
Weight Loss
Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2008




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