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Completed

NCT Number: NCT00152360

The Effect of Xenical on Weight and Risk Factors

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Healthy Heart Program/Lipid Clinic, St. Paul's Hospital

Vancouver, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orlistat

Drug

See Detailed Description.

Primary outcomes

  1. Weight loss

    Time frame: three months

Secondary outcomes

  1. Lipid profile and insulin, CRP

    Time frame: three months

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Sep 9, 2005
Registry last updated
Apr 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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