Comparison of Obesity Alleles Among Diverse Demographic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01396096
Recruitment Status : Recruiting
First Posted : July 18, 2011
Last Update Posted : May 24, 2018
Geisinger Clinic
Information provided by (Responsible Party):
New York University School of Medicine

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

Detailed Description:


  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 Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Obesity Alleles Among Diverse Demographic Patient Populations Undergoing Bariatric Surgery
Study Start Date : June 2011
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Complete comprehensive genetic analyses [ Time Frame: 01/01/2016 ]

Biospecimen Retention:   Samples With DNA
DNA will be extracted from 0.35ml of EDTA-anticoagulated whole blood using the Qiagen MagAttract DNA Blood Midi M48 Kit and Qiagen BioRobot M48 Workstation (Qiagen, Valencia, California) according to the manufacturer's directions.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
NYUMC/Bellevue: All patients seen in the Bariatric Surgery Program at Bellevue NYU Langone Weight Management Program: All patients who are at least post-op 2 years

Inclusion Criteria:

  • All patients who have undergone any type of bariatric surgery

Exclusion Criteria:

  • Patients who have not had bariatric surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01396096

United States, New York
NYU SOM Recruiting
New York, New York, United States, 10016
Contact: Heekoung Youn, MA    212-263-2174   
Sponsors and Collaborators
New York University School of Medicine
Geisinger Clinic
Principal Investigator: Manish Parikh, M.D. NYUSOM

Responsible Party: New York University School of Medicine Identifier: NCT01396096     History of Changes
Other Study ID Numbers: 10-00634
First Posted: July 18, 2011    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
Bariatric Surgery

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms