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
  Purpose

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.


Condition Intervention Phase
Famine
Procedure: Band adjustment and specimen collection
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effect of Lap Band Adjustment on Satiety Peptides

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • plasma concentrations of representative hormones of hunger and satiety [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • surveying hunger/satiety and behavior changes. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: July 2009
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Arm Procedure: Band adjustment and specimen collection
Clinical evaluation and sample collection before and after band adjustment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967122

Locations
United States, New York
NYUSOM
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Francois Fritz, M.D. NYUSOM
  More Information

No publications provided

Responsible Party: Heekoung A Youn, Research coordinator, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00967122     History of Changes
Other Study ID Numbers: NYUSWLP-BH
Study First Received: August 25, 2009
Last Updated: September 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
adjustment, hunger
Hunger/satiety changes before and after gastric band adjustment

ClinicalTrials.gov processed this record on September 18, 2014