The Effect of Xenical on Weight and Risk Factors
Primary Purpose
Obesity, Heart Diseases
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Orlistat
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, weight loss, cardiovascular risk factors, Obesity and obesity related pathology
Eligibility Criteria
Inclusion Criteria: Body mass index ≥ 27 with one risk factor for cardiovascular disease OR overweight/obese individuals with type 2 diabetes on standard hypoglycemic agents Recently prescribed Xenical at the St. Paul's Hospital Lipid Clinic Exclusion Criteria: Patients with previous experience using Xenical Patients currently using other weight loss medications. Unable to provide informed consent. Less than 19 years of age
Sites / Locations
- Healthy Heart Program/Lipid Clinic, St. Paul's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Xenical (Orlistat)
Arm Description
Investigating the effectiveness of Xenical on cardiovascular risk factors in the patients of St. Paul's Hospital Lipid Clinic
Outcomes
Primary Outcome Measures
Weight loss
Secondary Outcome Measures
Lipid profile and insulin, CRP
Full Information
NCT ID
NCT00152360
First Posted
September 7, 2005
Last Updated
March 28, 2013
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00152360
Brief Title
The Effect of Xenical on Weight and Risk Factors
Official Title
The Effect of Xenical on Weight, Risk Factors and Burden of Medication
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Heart Diseases
Keywords
Obesity, weight loss, cardiovascular risk factors, Obesity and obesity related pathology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xenical (Orlistat)
Arm Type
Experimental
Arm Description
Investigating the effectiveness of Xenical on cardiovascular risk factors in the patients of St. Paul's Hospital Lipid Clinic
Intervention Type
Drug
Intervention Name(s)
Orlistat
Intervention Description
See Detailed Description.
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
three months
Secondary Outcome Measure Information:
Title
Lipid profile and insulin, CRP
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body mass index ≥ 27 with one risk factor for cardiovascular disease OR overweight/obese individuals with type 2 diabetes on standard hypoglycemic agents
Recently prescribed Xenical at the St. Paul's Hospital Lipid Clinic
Exclusion Criteria:
Patients with previous experience using Xenical
Patients currently using other weight loss medications.
Unable to provide informed consent.
Less than 19 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiri Frohlich, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthy Heart Program/Lipid Clinic, St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Effect of Xenical on Weight and Risk Factors
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