Band Holiday Study
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||The Effect of Lap Band Adjustment on Satiety Peptides|
- plasma concentrations of representative hormones of hunger and satiety [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- surveying hunger/satiety and behavior changes. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||March 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
|No Intervention: No Arm||
Procedure: Band adjustment and specimen collection
Clinical evaluation and sample collection before and after band adjustment
AIMS: Our aims are to measure BMI and plasma concentrations of representative hormones before and after a band holiday, in addition to surveying hunger/satiety and behavior changes.
Materials and Methods:
Adults ≥ 18 years of age who previously underwent LAGB at New York University Medical Center and have lost sufficient excess body weight and agree to have their band temporarily loosened for a 2 week period will be invited by the health care provider to participate. Patients of both genders and all races are eligible for participation. Patients will need to consent to complete a questionnaire and to have blood drawn when the band is loosened and refilled. Patients will only be excluded if they are not willing to have their band loosened or if they will not present for follow-up.
For this pilot program we plan to enroll 15 patients. Since patients will serve as their own controls before and after meals as well as before and after band adjustments, we anticipate adequate power to assess for significant variations.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967122
|United States, New York|
|New York, New York, United States, 10016|
|Principal Investigator:||Francois Fritz, M.D.||NYUSOM|