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OpenTrials
Completed

NCT Number: NCT00967122

Band Holiday Study

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.

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NYUSOM

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Band adjustment and specimen collection

Procedure

Clinical evaluation and sample collection before and after band adjustment

Primary outcomes

  1. plasma concentrations of representative hormones of hunger and satiety

    Time frame: 2 weeks

Secondary outcomes

  1. surveying hunger/satiety and behavior changes.

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

The Effect of Lap Band Adjustment on Satiety Peptides

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 27, 2009
Registry last updated
Sep 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.