Intestinal Permeability in Obesity

NCT02292121 | Terminated

• 1 other identifier: P130402
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. We hypothesized that intestinal permeability is altered in obese subjects in comparison to lean subjects, linked to metabolic and inflammatory status and that these alterations are modified after gastric bypass.

Conditions

Obesity; Metabolic Diseases; Nutrition Disorders; Body Weight

Keywords

Obesity; Intestinal permeability; Adipose tissue inflammation; Low grade systemic inflammation; Bariatric surgery

Outcome Measures

Primary Outcomes (1)

• urinary lactitol / mannitol ratio by an intestinal permeability test (IPT)

  Measures of urinary lactitol / mannitol ratio by an intestinal permeability test (IPT) in obese patients before gastric bypass and 6 months after

  before gastric bypass and 6 months after

Secondary Outcomes (4)

• fasting zonulin serum concentrations

  before gastric bypass and 6 months after

• LPS serum concentrations

  before gastric bypass and 6 months after

• urinary lactitol / mannitol ratio by an intestinal permeability test (IPT)

  inclusion and after one month

• surgical samples during surgery (sub-cutaneous and visceral adipose tissue)

  intraoperative

Study Arms (3)

obese group

EXPERIMENTAL

40 obese subjects undergoing gastric bypass explored at baseline and 30 explored post-surgery at 6 months

Procedure: Intestinal permeability; Other: a solution of mannitol and lactitol

non-obese control group (T1)

ACTIVE COMPARATOR

30 non-obese control subjects investigated for bio-clinical measures, IPT, zonulin, and LPS

Procedure: Intestinal permeability; Other: a solution of mannitol and lactitol

non obese control group undergoing a surgery (T2)

NO INTERVENTION

40 non-obese candidates to a surgery that gives access to surgical jejunal samples to measure the expression of tight junctions proteins

Interventions

Intestinal permeability PROCEDURE

5h-intestinal permeability test 10-hour overnight fasting subject who first emptied his bladder drinks a solution of mannitol and lactitol. 2 hours after, the subject drinks 500mL of water in less than 30 minutes. All urine samples are collected during the 5h-test for measurement of lactitol and mannitol.

non-obese control group (T1); obese group

a solution of mannitol and lactitol OTHER

non-obese control group (T1); obese group

Eligibility Criteria

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

You may qualify if:

• \- 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

You may not qualify if:

• \- 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
• 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:

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institute of Cardiometabolism and Nutrition, France: collaborator

Study Sites (1)

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Obesity; Metabolic Diseases; Nutrition Disorders; Body Weight

Interventions

Intestinal Barrier Function; lactitol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Transport; Metabolism; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Christine POITOU, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 17, 2014
• Study Start: February 24, 2014
• Primary Completion: March 17, 2016
• Study Completion: March 17, 2016
• Last Updated: January 20, 2021

Record last verified: 2021-01

Locations

FR (1)