ObesityCOLOMBESNCT00632671
COLOMBES Project:Constitution of a Population-based Cohort of Obese Subjects With Longitudinal Long-term Follow-up
An observational study of Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 311 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2005to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Morbidly obese subjects
Who may be able to join
- BMI>35
Who cannot join
- previous bariatric surgery
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Constitution of a Population-based Cohort of Obese Subjects With Longitudinal Long-term Follow-up.
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.
Read the 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.
- Conditions
- Obesity
- Keywords
- Obesity cohort
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese persons cohorte | constitution of a prospective data collection (biological, clinical, paraclinical and questionnaires) in morbidly obese persons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of follow-up at annual visit
Measured: annual
Secondary outcomes (1)
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).
Measured: one and two years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startMar 2005
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Msika, MD, PhD, Principal investigator, Louis Mourier University Hospital (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632671
- Sponsor's protocol ID
- P040807
- Other IDs
- AOM04013
- Acronym
- COLOMBES
- Status last verified
- Dec 2013
- First submitted
- 29 Feb 2008
- Last updated
- 1 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constitution of a Population-based Cohort of Obese Subjects With Longitudinal Long-term Follow-up.
- ClinicalTrials.gov ID
- NCT00632671
- Acronym / sponsor ID
- COLOMBES / P040807
- Conditions
- Obesity
- Keywords
- Obesity cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 11 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese persons cohorte | – | –constitution of a prospective data collection (biological, clinical, paraclinical and questionnaires) in morbidly obese persons. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Morbidly obese subjects
Key inclusion criteria (1 listed)
- BMI>35
Key exclusion criteria (2 listed)
- previous bariatric surgery
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of follow-up at annual visit
Time frame: annual
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Msika, MD, PhD principal investigator
Louis Mourier University Hospital (AP-HP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of follow-up at annual visit (time frame: annual). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2014.