This trial is active, not recruiting.

Condition obesity
Sponsor Assistance Publique - Hôpitaux de Paris
Start date March 2005
End date June 2018
Trial size 311 participants
Trial identifier NCT00632671, AOM04013, P040807


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
constitution of a prospective data collection (biological, clinical, paraclinical and questionnaires) in morbidly obese persons.

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).
time frame: one and two years of follow-up

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - BMI>35 Exclusion Criteria: - previous bariatric surgery - pregnancy

Additional Information

Official title Constitution of a Population-based Cohort of Obese Subjects With Longitudinal Long-term Follow-up.
Principal investigator Simon Msika, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.