Comparison of Obesity Alleles Among Diverse Demographic Patients
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Comparison of Obesity Alleles Among Diverse Demographic Patient Populations Undergoing Bariatric Surgery|
- 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.
|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)|
- Establish feasibility of obtaining research consent on patients to collect clinical data, family history, and blood samples.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396096
|United States, New York|
|New York, New York, United States, 10016|
|Contact: Heekoung Youn, MA 212-263-2174 firstname.lastname@example.org|
|Principal Investigator:||Manish Parikh, M.D.||NYUSOM|