Band Holiday Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heekoung A Youn, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00967122
First received: August 25, 2009
Last updated: September 26, 2012
Last verified: September 2012

August 25, 2009
September 26, 2012
July 2009
January 2012   (final data collection date for primary outcome measure)
plasma concentrations of representative hormones of hunger and satiety [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00967122 on ClinicalTrials.gov Archive Site
surveying hunger/satiety and behavior changes. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Famine
Procedure: Band adjustment and specimen collection
Clinical evaluation and sample collection before and after band adjustment
No Intervention: No Arm
Intervention: Procedure: Band adjustment and specimen collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
March 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00967122
NYUSWLP-BH
No
Heekoung A Youn, New York University School of Medicine
New York University School of Medicine
Not Provided
Principal Investigator: Francois Fritz, M.D. NYUSOM
New York University School of Medicine
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP