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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01396096
Other study ID # 10-00634
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2011
Est. completion date January 2019

Study information

Verified date August 2018
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2500
Est. completion date January 2019
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients who have undergone any type of bariatric surgery

Exclusion Criteria:

- Patients who have not had bariatric surgery

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States NYU SOM New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York University School of Medicine Geisinger Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Complete comprehensive genetic analyses 01/01/2016
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