Intestinal Permeability in Obesity (LEAKY GUT)
Obesity, Metabolic Diseases, Nutrition Disorders
About this trial
This is an interventional diagnostic trial for Obesity focused on measuring Obesity, Intestinal permeability, Adipose tissue inflammation, Low grade systemic inflammation, Bariatric surgery
Eligibility Criteria
Inclusion criteria :
- Control subjects T1:
- Registered for social security
- Signed consent form
- male or female subject between 18 and 65 years old
- Fasting plasma triglycerides < 1.5 g/l (< 1.7 mmol/l)
- Fasting plasma total cholesterol < 2.5 g/l (< 6 mmol/l)
- fasting glycaemia < 5,5 mmol/l
- BMI <25kg/m² & >18 kg/m²
- Mean systolic blood pressure <140 mmHg and mean diastolic blood pressure < 90 mmHg.
Control subjects T2
- Registered for social security
- Signed consent form
- male or female subject between 18 and 70 years old
- IMC<25kg/m² et >18 kg/m²
- candidate to surgery giving access to jejunal samples
Obese subjects OB:
- Registered for social security
- Signed consent form
- male or female subject between 18 and 65 years old
- Candidate to bariatric surgery (bypass) with massive (IBMI >= 40 kg/m²) or severe obesity (BMI between 35 & 40 kg/m²) with at least one obesity-related comorbidity and with a stable weight (+/-5kg) for the last 3 months, after approval by a multidisciplinary team
Exclusion criteria :
- Control subjects T1:
- Subject with a history of vascular symptomatic disease in the last 6 months before selection.
- Subject receiving a treatment that can affect measured parameters
- Pregnancy
Subject with acute or chronic disease that can affect measured parameters or to life-threatening. Including but not limited :
- Diabetic subjects
- Subject with kidney disease: nephrotic syndrome, chronic renal failure
- Subject having a gastrointestinal disorder or disease limiting intestinal absorption (celiac disease), bariatric surgery.
- Active inflammatory disease or a history of IBD
- Subject in a situation that, according to the investigator's opinion could interfere with an optimal participation to the study or constitute a particular risk to the subject
- Subject in an exclusion period after participating in another clinical trial
- Adult person subject to legal protection or unable to consent.
- Persons deprived of their liberty by judicial or administrative decision
Control subjects T2
- Subject with a history of symptomatic vascular disease (myocardial infarction, angina syndrome threat, surgical or endovascular surgery, stroke, lower limb arteritis symptomatic) of less than 6 months
Subject with any acute or chronic disease which may influence the results of the study or to life-threatening. Including but not limiting:
- diabetic patients
- Subject with kidney disease: nephrotic syndrome, chronic renal failure and / or serum creatinine> 1.7 times the upper limit of the reference value
- Adult person subject to legal protection or unable to consent.
- Persons deprived of their liberty by judicial or administrative decision
Obese subjects candidates for surgery:
- Subject receiving treatment systemically or topically, which may interfere with the evaluation of the parameters studied (NSAIDs, antibiotics in the previous month)
- Any disease or psychosocial context making prolonged regular monitoring impossible, which also represents a contraindication for bariatric surgery.
- Adult person subject to legal protection or unable to consent.
- Persons deprived of their liberty by judicial or administrative decision
Sites / Locations
- Groupe Hospitalier Pitié-Salpêtrière
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
No Intervention
obese group
non-obese control group (T1)
non obese control group undergoing a surgery (T2)
40 obese subjects undergoing gastric bypass explored at baseline and 30 explored post-surgery at 6 months
30 non-obese control subjects investigated for bio-clinical measures, IPT, zonulin, and LPS
40 non-obese candidates to a surgery that gives access to surgical jejunal samples to measure the expression of tight junctions proteins