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Comparison of Obesity Alleles Among Diverse Demographic Patients

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT01396096
Collaborator
Geisinger Clinic (Other)
2,500
Enrollment
1
Location
160
Anticipated Duration (Months)
15.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This proposal is designed to (1) establish the feasibility of a research strategy for discovering ethnic differences in the frequency of genotypes in patients after bariatric surgery and (2) perform a preliminary evaluation of this research strategy. Our goal is to identify genetic factors that may influence the success of various surgical weight loss interventions and determine whether these factors are associated with specific patient populations.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Goals:

    1. Establish feasibility of obtaining research consent on patients to collect clinical data, family history, and blood samples.

    2. Complete comprehensive genetic analyses on a diverse group of severely obese patients who have undergone bariatric surgery, specifically the primarily non-Caucasian Bellevue population and the Caucasian population of Geisinger Health Systems and NYU Langone Weight Management Program, to help define genetic factors that influence which surgical interventions work best for which patients. The ultimate aim is to rapidly translate these discoveries into practical solutions.

    Methods and Procedures: The participants of this study are all patients who have undergone bariatric surgery at Bellevue Hospital, NYU Langone Weight Management Program, and Geisinger Health System. The investigators have already completed this in 200 patients and plan to increase enrollment for a total of 2500 patients. The investigators will collect blood samples on bariatric surgery patients and send the blood to Geisinger for genotyping and analysis. An extra sample of venous blood (about 4 tablespoons or 40ml) will be collected at the time of routine postoperative visits. In addition, the investigators will use information that has routinely been and will be collected during postoperative visits as part of the care that bariatric patients receive. The investigators will look at the electronic medical record to obtain the preoperative weights. This includes questionnaires patients complete and the results of the laboratory tests and other studies.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2500 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Comparison of Obesity Alleles Among Diverse Demographic Patient Populations Undergoing Bariatric Surgery
    Actual Study Start Date :
    Jun 1, 2011
    Anticipated Primary Completion Date :
    Oct 1, 2024
    Anticipated Study Completion Date :
    Oct 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Complete comprehensive genetic analyses [01/01/2016]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients who have undergone any type of bariatric surgery
    Exclusion Criteria:
    • Patients who have not had bariatric surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NYU Langone Health New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health
    • Geisinger Clinic

    Investigators

    • Principal Investigator: Manish Parikh, M.D., NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT01396096
    Other Study ID Numbers:
    • 10-00634
    First Posted:
    Jul 18, 2011
    Last Update Posted:
    Feb 28, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by NYU Langone Health
    Bariatric Surgery
    Additional relevant MeSH terms:
    Obesity

    Study Results

    No Results Posted as of Feb 28, 2022