Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00152360
Status:
COMPLETED
Last Update Posted:
2013-04-01
First Post:
2005-09-07
Brief Title:
The Effect of Xenical on Weight and Risk Factors
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
The Effect of Xenical on Weight Risk Factors and Burden of Medication
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Pauls Hospital over a three month period Xenical works by blocking the bodys 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 medicationsThis is a pilot study to investigate the effectiveness of Xenical on cardiovascular risk factors in the patients of St Pauls Hospital Lipid Clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None