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临床试验/NCT00152360
NCT00152360已完成4 期

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

University of British Columbia1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2005年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
25
试验地点
1
主要终点
Weight loss

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients with previous experience using Xenical
  • Patients currently using other weight loss medications.
  • Unable to provide informed consent.
  • Less than 19 years of age

研究组 & 干预措施

Xenical (Orlistat)

Experimental

Investigating the effectiveness of Xenical on cardiovascular risk factors in the patients of St. Paul's Hospital Lipid Clinic

干预措施: Orlistat (Drug)

结局指标

主要结局

Weight loss

时间窗: three months

次要结局

  • Lipid profile and insulin, CRP(three months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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