Band Holiday Study
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Sample size:
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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.
Exclusion criteria
- < %35 Excess weight loss
Trial design
Primary purpose
Allocation
Interventional model
Masking
15 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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