COLOMBES Project:Constitution of a Population-based Cohort of Obese Subjects With Longitudinal Long-term Follow-up (COLOMBES)
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|ClinicalTrials.gov Identifier: NCT00632671|
Recruitment Status : Active, not recruiting
First Posted : March 11, 2008
Last Update Posted : January 1, 2014
|Condition or disease|
The objective of this observational study is the follow-up of a cohort of 500 adult persons with morbid obesity (BMI>35 kg/m2).
Clinical and paraclinical data, and biological samples (plasma, serum, DNA, RNA, cell blood, for persons undergoing bariatric surgery (specific consent): samples of liver and adipocytes) will be collected and stored during the follow-up visits. These visits take place at inclusion, at 6 months, twelve months and every year for ten years. The collection of parental DNA will be proposed when feasable for genetic studies.
Persons will be recruited for four years, with an expected number of 350 persons included, in the clinical research unit of Louis MOURIER university hospital (AP-HP).
Each person included will participate in the study for ten years. When included, patients agree to come every year to follow-up visits. They are informed that data collected will be used only for research on obesity and its health consequences.
|Study Type :||Observational|
|Actual Enrollment :||311 participants|
|Official Title:||Constitution of a Population-based Cohort of Obese Subjects With Longitudinal Long-term Follow-up.|
|Study Start Date :||March 2005|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Obese persons cohorte
constitution of a prospective data collection (biological, clinical, paraclinical and questionnaires) in morbidly obese persons.
- Rate of follow-up at annual visit [ Time Frame: annual ]
- Assessment of knee arthrosis (pain and radiological exam), at inclusion and after loss-weight (comparison after one and two years of follow-up of patients that did or did not undergo bariatric surgery). [ Time Frame: one and two years of follow-up ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632671
|Louis Mourier hospital (AP-HP)|
|Colombes, France, 92700|
|Principal Investigator:||Simon Msika, MD, PhD||Louis Mourier University Hospital (AP-HP)|