COLOMBES Project:Constitution of a Population-based Cohort of Obese Subjects With Longitudinal Long-term Follow-up
| Tracking Information | |||||
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| First Received Date ICMJE | February 29, 2008 | ||||
| Last Updated Date | January 9, 2012 | ||||
| Start Date ICMJE | March 2005 | ||||
| Estimated Primary Completion Date | June 2018 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Rate of follow-up at annual visit [ Time Frame: annual ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00632671 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | COLOMBES Project:Constitution of a Population-based Cohort of Obese Subjects With Longitudinal Long-term Follow-up | ||||
| Official Title ICMJE | Constitution of a Population-based Cohort of Obese Subjects With Longitudinal Long-term Follow-up. | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: plasma, serum, DNA, RNA, cell blood, for persons undergoing bariatric surgery (specific consentment): samples of liver and adipocytes |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Morbidly obese subjects |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Obese persons cohorte
constitution of a prospective data collection (biological, clinical, paraclinical and questionnaires) in morbidly obese persons. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 311 | ||||
| Estimated Completion Date | June 2018 | ||||
| Estimated Primary Completion Date | June 2018 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00632671 | ||||
| Other Study ID Numbers ICMJE | P040807, AOM04013 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | February 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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