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

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ClinicalTrials.gov Identifier: NCT01035333
Recruitment Status : Completed
First Posted : December 18, 2009
Results First Posted : April 4, 2014
Last Update Posted : April 4, 2014
Sponsor:
Collaborator:
Albany Medical College
Information provided by (Responsible Party):
Margaret Malone, 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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Orlistat Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : November 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Orlistat
U.S. FDA Resources

Arm Intervention/treatment
Experimental: orlistat 60mg
Patients assigned to treatment group for up to 6 months of therapy.
Drug: Orlistat
60mg capsule three times a day for up to 6 months
Other Name: Alli



Primary Outcome Measures :
  1. Weight Loss [ Time Frame: 6 months ]
    Weight loss acheived during time on study up to 6 months.


Secondary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients preparing for gastric bypass surgery

Exclusion Criteria:

  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01035333


Locations
United States, New York
Albany College of Pharmacy and Health Sciences
Albany, New York, United States, 12208
Sponsors and Collaborators
Albany College of Pharmacy and Health Sciences
Albany Medical College
Investigators
Principal Investigator: Margaret Malone, PhD Albany College of Pharmacy and Health Sciences

Responsible Party: Margaret Malone, Dr, Albany College of Pharmacy and Health Sciences
ClinicalTrials.gov Identifier: NCT01035333     History of Changes
Other Study ID Numbers: 09-016
First Posted: December 18, 2009    Key Record Dates
Results First Posted: April 4, 2014
Last Update Posted: April 4, 2014
Last Verified: February 2014

Keywords provided by Margaret Malone, Albany College of Pharmacy and Health Sciences:
gastric bypass surgery

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents