NCT00632671

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
311

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 11, 2008

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 1, 2014

Status Verified

December 1, 2013

Enrollment Period

13.3 years

First QC Date

February 29, 2008

Last Update Submit

December 31, 2013

Conditions

Obesity

Keywords

Obesity cohort

Outcome Measures

Primary Outcomes (1)

  • Rate of follow-up at annual visit

    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).

    one and two years of follow-up

Study Arms (1)

Obese persons cohorte

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Morbidly obese subjects

You may qualify if:

  • BMI\>35

You may not qualify if:

  • previous bariatric surgery
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Mourier hospital (AP-HP)

Colombes, 92700, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Simon Msika, MD, PhD

    Louis Mourier University Hospital (AP-HP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2008

First Posted

March 11, 2008

Study Start

March 1, 2005

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

January 1, 2014

Record last verified: 2013-12

Locations

FR(1)