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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

March 28, 2013

Start Date ^ICMJE

June 2005

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Weight loss [ Time Frame: three months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Weight loss ( three months )

Change History

Complete list of historical versions of study NCT00152360 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Lipid profile and Insulin, CRP ( three months)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Effect of Xenical on Weight and Risk Factors

Official Title ^ICMJE

The Effect of Xenical on Weight, Risk Factors and Burden of Medication

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Obesity
Heart Diseases

Intervention ^ICMJE

Drug: Orlistat

See Detailed Description.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2013

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00152360

Other Study ID Numbers ^ICMJE

P03-0151

Has Data Monitoring Committee

Responsible Party

University of British Columbia

Study Sponsor ^ICMJE

University of British Columbia

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jiri Frohlich, MD

University of British Columbia

Information Provided By

University of British Columbia

Verification Date

March 2013

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

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