Band Holiday Study
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|ClinicalTrials.gov Identifier: NCT00967122|
Recruitment Status : Completed
First Posted : August 27, 2009
Last Update Posted : September 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Famine||Procedure: Band adjustment and specimen collection||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effect of Lap Band Adjustment on Satiety Peptides|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||March 2012|
|No Intervention: No Arm||
Procedure: Band adjustment and specimen collection
Clinical evaluation and sample collection before and after band adjustment
- plasma concentrations of representative hormones of hunger and satiety [ Time Frame: 2 weeks ]
- surveying hunger/satiety and behavior changes. [ Time Frame: 2 weeks ]
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): NCT00967122
|United States, New York|
|New York, New York, United States, 10016|
|Principal Investigator:||Francois Fritz, M.D.||NYUSOM|