Clinical trial NCT01396096: Comparison of Obesity Alleles Among Diverse Demographic Patients
Official title: Comparison of Obesity Alleles Among Diverse Demographic Patient Populations Undergoing Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity
Keywords: Bariatric Surgery
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Geisinger Clinic
First posted: 2011-07-18
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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 criteria: Inclusion Criteria:

* All patients who have undergone any type of bariatric surgery

Exclusion Criteria:

* Patients who have not had bariatric surgery

Primary outcomes:
measure: Complete comprehensive genetic analyses
timeFrame: 01/01/2016
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Manish Parikh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walley AJ, Blakemore AI, Froguel P. Genetics of obesity and the prediction of risk for health. Hum Mol Genet. 2006 Oct 15;15 Spec No 2:R124-30. doi: 10.1093/hmg/ddl215.