The Effect of Xenical on Weight and Risk Factors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00152360
First received: September 7, 2005
Last updated: March 28, 2013
Last verified: March 2013

September 7, 2005
March 28, 2013
June 2005
March 2013   (final data collection date for primary outcome measure)
Weight loss [ Time Frame: three months ] [ Designated as safety issue: No ]
Weight loss ( three months )
Complete list of historical versions of study NCT00152360 on ClinicalTrials.gov Archive Site
Lipid profile and insulin, CRP [ Time Frame: three months ] [ Designated as safety issue: No ]
Lipid profile and Insulin, CRP ( three months)
Not Provided
Not Provided
 
The Effect of Xenical on Weight and Risk Factors
The Effect of Xenical on Weight, Risk Factors and Burden of Medication

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Heart Diseases
Drug: Orlistat
See Detailed Description.
Experimental: Xenical (Orlistat)
Investigating the effectiveness of Xenical on cardiovascular risk factors in the patients of St. Paul's Hospital Lipid Clinic
Intervention: Drug: Orlistat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
19 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00152360
P03-0151
No
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Jiri Frohlich, MD University of British Columbia
University of British Columbia
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP