Obesity Cohort Bichat Louis Mourier

NCT03538210 | Completed

• 1 other identifier: K170704J
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Obesity; Bariatric Surgery; Surgical Failure

Keywords

obesity, bariatric surgery, gastrointestinal functions, adipose tissu, steatohepatitis

Outcome Measures

Primary Outcomes (1)

• number of biological samples collected

  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

  during surgery

Secondary Outcomes (4)

• modifications of gastro-intestinal plasticity induces by obesity and bariatric surgery

  samples collected during surgery

• alterations of absroption and metabolism of nutriments induced by obesity and bariatric surgery

  samples collected during surgery

• gastric and intestinal proteome

  samples collected during surgery

• tissue inflammation and fibrosis

  samples collected during surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

severe obese subjects operated for bariatric surgery or reoperated for complication

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Lousi Mourier (HUPNVS)

Colombes, Île-de-France Region, 92700, France

Location

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Fatty Liver

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: May 29, 2018
• Study Start: February 16, 2018
• Primary Completion: March 3, 2026
• Study Completion: March 3, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

FR (1)