Back to resultsA Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery.
Primary Purpose
Obesity
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Orlistat
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring gastric bypass surgery
Eligibility Criteria
Inclusion Criteria:
- adult patients preparing for gastric bypass surgery
Exclusion Criteria:
- pregnancy
Sites / Locations
- Albany College of Pharmacy and Health Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
orlistat 60mg
Arm Description
Patients assigned to treatment group for up to 6 months of therapy.
Outcomes
Primary Outcome Measures
Weight Loss
Weight loss acheived during time on study up to 6 months.
Secondary Outcome Measures
Patient Satisfaction
Full Information
NCT ID
NCT01035333
First Posted
December 15, 2009
Last Updated
February 25, 2014
Sponsor
Albany College of Pharmacy and Health Sciences
Collaborators
Albany Medical College
1. Study Identification
Unique Protocol Identification Number
NCT01035333
Brief Title
A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery.
Official Title
A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany College of Pharmacy and Health Sciences
Collaborators
Albany Medical College
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary goal of the study is to determine if orlistat 60mg (Alli) is effective in helping patients achieve a required 10% weight loss goal prior to bariatric surgery. The medication will be added to the usual standard of care which includes education regarding diet and exercise and monthly meetings with a registered dietician.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
gastric bypass surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
orlistat 60mg
Arm Type
Experimental
Arm Description
Patients assigned to treatment group for up to 6 months of therapy.
Intervention Type
Drug
Intervention Name(s)
Orlistat
Other Intervention Name(s)
Alli
Intervention Description
60mg capsule three times a day for up to 6 months
Primary Outcome Measure Information:
Title
Weight Loss
Description
Weight loss acheived during time on study up to 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients preparing for gastric bypass surgery
Exclusion Criteria:
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Malone, PhD
Organizational Affiliation
Albany College of Pharmacy and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany College of Pharmacy and Health Sciences
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery.
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