Band Holiday Study

The Effect of Lap Band Adjustment on Satiety Peptides

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.

Study Overview

• Status: Completed
• Conditions: Famine
• Intervention / Treatment: Procedure: Band adjustment and specimen collection

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYUSOM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Arm	Procedure: Band adjustment and specimen collection; Clinical evaluation and sample collection before and after band adjustment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
plasma concentrations of representative hormones of hunger and satiety	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
surveying hunger/satiety and behavior changes.	2 weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Francois Fritz, M.D., NYUSOM

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: August 25, 2009
• First Submitted That Met QC Criteria: August 26, 2009
• First Posted (Estimate): August 27, 2009

Study Record Updates

• Last Update Posted (Estimate): September 27, 2012
• Last Update Submitted That Met QC Criteria: September 26, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: adjustment, hunger; Hunger/satiety changes before and after gastric band adjustment
• Other Study ID Numbers: NYUSWLP-BH