A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery.

Phase 4

Completed

• Conditions: Obesity
• Interventions: Drug: Orlistat

• Registration Number: NCT01035333
• Lead Sponsor: Albany College of Pharmacy and Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-17
• Study First Posted: 2009-12-18
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2014-01-08
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-25
• Last Update Submitted: 2014-02-25
• Results First Posted: 2014-04-04
• Last Update Posted: 2014-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• adult patients preparing for gastric bypass surgery

Exclusion Criteria

• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
orlistat 60mg	Orlistat	Patients assigned to treatment group for up to 6 months of therapy.

Primary Outcome Measures

Name	Time	Method
Weight Loss	6 months	Weight loss acheived during time on study up to 6 months.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	6 months

Trial Locations

Locations (1)

Albany College of Pharmacy and Health Sciences; 🇺🇸 Albany, New York, United States