Status:
TERMINATED
Intestinal Permeability in Obesity
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institute of Cardiometabolism and Nutrition, France
Conditions:
Obesity
Metabolic Diseases
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
In rodents, obesity is associated with changes in tight junctions' structure in small intestine, which impacts intestinal permeability and results in metabolic complications. Few data exist in human. ...
Detailed Description
The regulation of the permeability of the intestinal barrier is essential in the molecular traffic between the lumen and the internal environment. It affects the absorption of nutrients and tolerance ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 24 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02292121
Start Date
February 24 2014
End Date
March 17 2016
Last Update
January 20 2021
Active Locations (1)
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1
Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013