Comparison of Obesity Alleles Among Diverse Demographic Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by New York University School of Medicine
Sponsor:
Collaborator:
Geisinger Clinic
Information provided by (Responsible Party):
Heekoung A Youn, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01396096
First received: July 12, 2011
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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
Obesity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Obesity Alleles Among Diverse Demographic Patient Populations Undergoing Bariatric Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Complete comprehensive genetic analyses [ Time Frame: 01/01/2016 ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 2500
Study Start Date: June 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

  • All patients who have undergone any type of bariatric surgery

Exclusion Criteria:

  • Patients who have not had bariatric surgery
  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: NCT01396096

Locations
United States, New York
NYU SOM Recruiting
New York, New York, United States, 10016
Contact: Heekoung Youn, MA    212-263-2174    younh01@nyumc.org   
Sponsors and Collaborators
New York University School of Medicine
Geisinger Clinic
Investigators
Principal Investigator: Manish Parikh, M.D. NYUSOM
  More Information

Publications:
Responsible Party: Heekoung A Youn, Research coordinator, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01396096     History of Changes
Other Study ID Numbers: 10-00634
Study First Received: July 12, 2011
Last Updated: May 19, 2014
Health Authority: United States: NYU SOM IRB

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

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

ClinicalTrials.gov processed this record on July 24, 2014