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Band Holiday Study

The Effect of Lap Band Adjustment on Satiety Peptides

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00967122
Enrollment
15
Registered
2009-08-27
Start date
2009-07-31
Completion date
2012-03-31
Last updated
2012-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Famine

Keywords

adjustment, hunger, Hunger/satiety changes before and after gastric band adjustment

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.

Interventions

PROCEDUREBand adjustment and specimen collection

Clinical evaluation and sample collection before and after band adjustment

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
plasma concentrations of representative hormones of hunger and satiety2 weeks

Secondary

MeasureTime frame
surveying hunger/satiety and behavior changes.2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026