COLOMBES Project:Constitution of a Population-Based Cohort of Obese Subjects With Longitudinal Long-Term Follow-up - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00632671

Purpose

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.

Condition
Obesity

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Constitution of a Population-Based Cohort of Obese Subjects With Longitudinal Long-Term Follow-up.

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Rate of follow-up at annual visit [ Time Frame: annual ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

plasma, serum, DNA, RNA, cell blood, for persons undergoing bariatric surgery (specific consentment): samples of liver and adipocytes

Estimated Enrollment:	500
Study Start Date:	March 2005
Estimated Study Completion Date:	June 2018
Estimated Primary Completion Date:	June 2018 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Morbidly obese subjects

Criteria

Inclusion Criteria:

BMI>35

Exclusion Criteria:

previous bariatric surgery
pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632671

Contacts

Contact: Laurence SALOMON, MD, PhD

+33(0) 1 47 60 67 27

laurence.salomon@lmr.aphp.fr

Locations

France
Louis Mourier hospital (AP-HP)	Recruiting
Colombes, France, 92700
Contact: Laurence SALOMON, MD, PhD +33(0) 1 47 60 67 27 laurence.salomon@lmr.aphp.fr
Principal Investigator: Simon Msika, MD, PhD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Simon Msika, MD, PhD

Louis Mourier University Hospital (AP-HP)

More Information

No publications provided

Responsible Party:	Department Clinical Research ( VACHER Yannick )
Study ID Numbers:	P040807, AOM04013
Study First Received:	February 29, 2008
Last Updated:	March 14, 2008
ClinicalTrials.gov Identifier:	NCT00632671 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Obesity cohort

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on September 10, 2009