NCT00152360

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4 obesity

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 1, 2013

Status Verified

March 1, 2013

Enrollment Period

7.8 years

First QC Date

September 7, 2005

Last Update Submit

March 28, 2013

Conditions

ObesityHeart Diseases

Keywords

Obesityweight losscardiovascular risk factorsObesity and obesity related pathology

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    three months

Secondary Outcomes (1)

  • Lipid profile and insulin, CRP

    three months

Study Arms (1)

Xenical (Orlistat)

EXPERIMENTAL

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

Drug: Orlistat

Interventions

OrlistatDRUG

See Detailed Description.

Xenical (Orlistat)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

ObesityHeart DiseasesWeight Loss

Interventions

Orlistat

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCardiovascular DiseasesBody Weight Changes

Intervention Hierarchy (Ancestors)

LactonesOrganic Chemicals

Study Officials

  • Jiri Frohlich, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 9, 2005

Study Start

June 1, 2005

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 1, 2013

Record last verified: 2013-03

Locations

CA(1)