Band Holiday Study

Phase 1

Completed

• Conditions: Famine
• Interventions: Procedure: Band adjustment and specimen collection

• Registration Number: NCT00967122
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed 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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-25
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Primary Completion: 2012-01
• Study Completion: 2012-03
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-26
• Last Update Posted: 2012-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No Arm	Band adjustment and specimen collection	-

Primary Outcome Measures

Name	Time	Method
plasma concentrations of representative hormones of hunger and satiety	2 weeks

Secondary Outcome Measures

Name	Time	Method
surveying hunger/satiety and behavior changes.	2 weeks

Trial Locations

Locations (1)

NYUSOM; 🇺🇸 New York, New York, United States