ObesityNCT01396096
Comparison of Obesity Alleles Among Diverse Demographic Patients
An observational study of Obesity, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 24 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- All patients who have undergone any type of bariatric surgery
Who cannot join
- Patients who have not had bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Obesity Alleles Among Diverse Demographic Patient Populations Undergoing Bariatric Surgery
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.
Read the detailed description
Goals:
- 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.
- Conditions
- Obesity
- Keywords
- Bariatric Surgery
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete comprehensive genetic analyses
Measured: 01/01/2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startJun 2011
- Primary completion10 Sep 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Geisinger Clinic
- Responsible party
- Sponsor
- Investigators
- Manish Parikh, M.D., Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396096
- Sponsor's protocol ID
- 10-00634
- Status last verified
- Mar 2026
- First submitted
- 12 Jul 2011
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16987875
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Obesity Alleles Among Diverse Demographic Patient Populations Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01396096
- Acronym / sponsor ID
- 10-00634
- Conditions
- Obesity
- Keywords
- Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Geisinger Clinic
- Study start
- Jun 2011 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 18 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All patients who have undergone any type of bariatric surgery
Key exclusion criteria (1 listed)
- Patients who have not had bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete comprehensive genetic analyses
Time frame: 01/01/2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 16987875Walley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manish Parikh, M.D. principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete comprehensive genetic analyses (time frame: 01/01/2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01396096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.