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Clinical Trials/NCT00632671
NCT00632671
Unknown
Not Applicable

Constitution of a Population-based Cohort of Obese Subjects With Longitudinal Long-term Follow-up.

Assistance Publique - Hôpitaux de Paris1 site in 1 country311 target enrollmentMarch 2005
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
311
Locations
1
Primary Endpoint
Rate of follow-up at annual visit
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
June 2018
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • previous bariatric surgery
  • pregnancy

Outcomes

Primary Outcomes

Rate of follow-up at annual visit

Time Frame: annual

Secondary Outcomes

  • 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)

Study Sites (1)

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