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

NCT ID: NCT00632671

Last Updated: 2014-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

311 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Obese persons cohorte

constitution of a prospective data collection (biological, clinical, paraclinical and questionnaires) in morbidly obese persons.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* BMI\>35

Exclusion Criteria

* previous bariatric surgery
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon Msika, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Louis Mourier University Hospital (AP-HP)

Locations

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Louis Mourier hospital (AP-HP)

Colombes, , France

Site Status

Countries

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France

Other Identifiers

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AOM04013

Identifier Type: OTHER

Identifier Source: secondary_id

P040807

Identifier Type: -

Identifier Source: org_study_id

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