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Obesity Cohort Bichat Louis Mourier (COBILOM)

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ClinicalTrials.gov Identifier: NCT03538210
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Obesity prevalence rapidly increased in the past decades in French population with multiple health consequences responsible for excess mortality. In the same period of time, the number of bariatric procedures have developed exponentially. Despite its great efficacy on weight loss but also on resolution of comorbidities, bariatric surgery is not without risks. Our hypothesis is that a better understanding of the physio-pathological consequences of obesity and bariatric surgery, notably on the gastrointestinal tract, may allow to improve the treatment of obesity and to find alternatives to bariatric surgery.

The main objective of this cohort study is to systematize the collection and the conservation of biological samples (blood, stomach, liver, intestine, adipose tissue) obtained during bariatric surgery, in obese subjects undergoing surgery (including sleeve gastrectomy, Roux-en-Y gastric bypass, or revisional intervention for complication or weight regain) in the University Hospital group of Paris Nord Val de Seine (HYPNVS).

The main projects that will build on this cohort will cover the physiopathology of obesity and its consequences, notably in the field of gastrointestinal tract including: modification of gastro-intestinal plasticity in severe obesity and after bariatric surgery and alterations of absorption of nutriments (lipids, proteins, carbohydrates) induced by obesity and bariatric surgery. The inclusion in this project of obese subjects before surgery, or lean or obese subjects after surgery will allow to distinguish the impact of weight loss and surgery on gastrointestinal remodeling. This cohort will also allow to characterize stomach and intestinal proteome in severe obesity and to precise the influence of tissue inflammation on metabolic disorders associated with obesity.


Condition or disease
Severe Obesity Bariatric Surgery Surgical Failure

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 420 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohorte Obésité Bichat LOuis Mourier
Actual Study Start Date : February 16, 2018
Estimated Primary Completion Date : June 16, 2020
Estimated Study Completion Date : September 16, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. number of biological samples collected [ Time Frame: during surgery ]
    liver stomach and intestin samples will be performed during surgery for usual care. Adiposes tissues and blood samples will be performed for reseach, on the surgical site


Secondary Outcome Measures :
  1. modifications of gastro-intestinal plasticity induces by obesity and bariatric surgery [ Time Frame: samples collected during surgery ]
    gene expression of basic helix-loop-helix transcription factors (fold increase as compared to control)

  2. alterations of absroption and metabolism of nutriments induced by obesity and bariatric surgery [ Time Frame: samples collected during surgery ]
    intestinal protein expression of monosaccharides, proteins, fatty acids and cholesterol transporters (fold increase as compare to control)

  3. gastric and intestinal proteome [ Time Frame: samples collected during surgery ]
    gastric and intestinal proteome in the obese morbid subject assessed by mass spectrometry

  4. tissue inflammation and fibrosis [ Time Frame: samples collected during surgery ]
    quantification of the inflammatory infiltrate of the visceral and subcutaneous adipose tissue, liver and intestine (number per area)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
severe obese subjects operated for bariatric surgery or reoperated for complication
Criteria

Inclusion Criteria:

  • severe obese subject with BMI above35 kg/m2, age above 18 ans who accept to participate
  • candidate for bariatric surgery according to HAS criteria
  • who will undergo either sleeve gastrectomy or gastric bypass
  • or who undergoesa revisional surgery for a complication of bariatric surgery
  • or who undergoes arevisional sugery fir insufficient weight loss
  • covered by an health insurance

Exclusion Criteria:

  • psychiatric disease or undertanding disorder
  • alchool abuse or other addiction
  • organ failure (including liver, heart or kidney)
  • chronic life-threatening illness
  • inflamatory disease or immunosuppressive treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538210


Contacts
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Contact: Séverine LEDOUX, Md, PhD 147606256 ext +33 severine.ledoux@aphp.fr
Contact: André BADO, PhD andre.bado@inserm.fr

Locations
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France
Hôpital Lousi Mourier (HUPNVS) Recruiting
Colombes, Ile De France, France, 92700
Contact: Séverine LEDOUX, Md, PhD    147606256 ext +33    severine.ledoux@aphp.fr   
Contact: André BADO, PhD       andre.bado@inserm.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03538210    
Other Study ID Numbers: 2017SLX1085
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: May 29, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
obesity, bariatric surgery, gastrointestinal functions, adipose tissu, steatohepatitis
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms