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Band Holiday Study

2014-08-27 03:19:44 | BioPortfolio

Summary

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.

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.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Conditions

Famine

Intervention

Band adjsutment and specimen collection

Location

NYUSOM
New York
New York
United States
10016

Status

Recruiting

Source

New York University School of Medicine

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:44-0400

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