Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders (EnteroNeurObesity)
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.
|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)|
- T1/2 solids (on the kinetic of isotopic gastric empty exam) [ Time Frame: 6 months ] [ Designated as safety issue: No ]This evaluation will be obtained before bariatric surgery for patients and at any time before end of study for volunteers.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01810146
|Contact: Stanislas BRULEY DES VARANNES, Professor||+ 33 2 40 08 33 email@example.com|
|Nantes, France, 44000|
|Contact: Stanislas BRULEY DES VARANNES, Professor +33 2 40 08 33 06 firstname.lastname@example.org|