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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01035333
First Posted: December 18, 2009
Last Update Posted: April 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Albany Medical College
Information provided by (Responsible Party):
Margaret Malone, Albany College of Pharmacy and Health Sciences
  Purpose
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 Intervention Phase
Obesity Drug: Orlistat Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Margaret Malone, Albany College of Pharmacy and Health Sciences:

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


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

Enrollment: 19
Study Start Date: November 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
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
  More Information

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 Submitted: December 15, 2009
First Posted: December 18, 2009
Results First Submitted: January 8, 2014
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