A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery.
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery.|
- Weight Loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]Weight loss acheived during time on study up to 6 months.
- Patient Satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: orlistat 60mg
Patients assigned to treatment group for up to 6 months of therapy.
60mg capsule three times a day for up to 6 months
Other Name: Alli
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035333
|United States, New York|
|Albany College of Pharmacy and Health Sciences|
|Albany, New York, United States, 12208|
|Principal Investigator:||Margaret Malone, PhD||Albany College of Pharmacy and Health Sciences|