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Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders (EnteroNeurObesity)

This study has been completed.
Information provided by (Responsible Party):
Nantes University Hospital Identifier:
First received: January 7, 2013
Last updated: November 20, 2014
Last verified: November 2014
60 patients scheduled for bariatric surgery will be included into 3 categories (20 patients with non complicated obesity, 20 patients with metabolic syndrome and 20 patients with a type 2 diabetes or hypertension). 20 volunteers will be enrolled as normal referents. The patients and the volunteers will have a classical pre-operative check-up (fibroscopy, oesophageal pHmetry and manometry) and extra investigations as isotopic gastric empty exam, lactulose oro-caecal transit exam, intestinal permeability test calculated by lactulose-manitol ratio urinary excretion. Intestinal and colonic biopsies will be also provided for studying permeability. For only patients, samples from the gastric resection will be provided for analysing the enteric nervous system and motricity.

Condition Intervention
Other: Digestive functions investigations

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders(EnteroNeurObesity)

Resource links provided by NLM:

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • T1/2 solids (on the kinetic of isotopic gastric empty exam) [ Time Frame: 6 months ]
    This evaluation will be obtained before bariatric surgery for patients and at any time before end of study for volunteers.

Enrollment: 40
Study Start Date: September 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Digestive functions investigations
Results from digestive functions investigations will be compared between patients eligible for bariatric surgery (BMI>40kg/m2) and volunteers (BMI between 20 and 25kg/m2).
Other: Digestive functions investigations


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


Patients must be aged between 18 and 65 years old with a BMI>40kg/m2 for non complicated patients or with a metabolic syndrome and with a BMI>35kg/m2 for patients with type 2 diabetes or hypertension. They must be eligible for bariatric surgery.

Patients with a type 1 diabetes, neurologic or neuro-degenerative disease will be excluded.


Volunteers must be aged between 18 and 65 years old with a BMI between 20 and 25kg/m2 Men and women are eligible.

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Please refer to this study by its identifier: NCT01810146

University Hospital
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital
  More Information

Responsible Party: Nantes University Hospital Identifier: NCT01810146     History of Changes
Other Study ID Numbers: RC12_0022
Study First Received: January 7, 2013
Last Updated: November 20, 2014

Keywords provided by Nantes University Hospital:
Patients eligible for bariatric surgery (BMI>40kg/m2)

Additional relevant MeSH terms:
Metabolic Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on May 24, 2017