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:
Collaborator:
Albany Medical College
Information provided by (Responsible Party):
Margaret Malone, Albany College of Pharmacy and Health Sciences
ClinicalTrials.gov Identifier:
NCT01035333
First received: December 15, 2009
Last updated: February 25, 2014
Last verified: February 2014
  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: 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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Weight loss acheived during time on study up to 6 months.


Secondary Outcome Measures:
  • Patient Satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients preparing for gastric bypass surgery

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 15, 2009
Results First Received: January 8, 2014
Last Updated: February 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014