COLOMBES Project:Constitution of a Population-based Cohort of Obese Subjects With Longitudinal Long-term Follow-up

• Conditions: Obesity

• Registration Number: NCT00632671
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The objective of the project is the constitution of a population-based cohort of 500 persons with severe or morbid obesity (BMI over 35 kg/m2) with annual follow-up for 10 years. It aims to improve the physiopathological, epidemiological and prognostic knowledge of obesity and its consequences. Clinical data, biological material, exams and questionaires will be collected and stored, allowing the realisation of research works, initiated by research teams from our hospital or from other settings.

Detailed Description

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 Timeline

• Study Start: 2005-03
• Study First Submitted: 2008-02-29
• Study First Submitted QC: 2008-03-10
• Study First Posted: 2008-03-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-31
• Last Update Posted: 2014-01-01
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 311

Inclusion Criteria

• BMI>35

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Exclusion Criteria

• previous bariatric surgery
• pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of follow-up at annual visit	annual

Secondary Outcome Measures

Name	Time	Method
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).	one and two years of follow-up

Trial Locations

Locations (1)

Louis Mourier hospital (AP-HP); 🇫🇷 Colombes, France