Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders (EnteroNeurObesity)
- Conditions
- Obesity
- Interventions
- Other: Digestive functions investigations
- Registration Number
- NCT01810146
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Digestive functions investigations 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).
- Primary Outcome Measures
Name Time Method T1/2 solids (on the kinetic of isotopic gastric empty exam) 6 months This evaluation will be obtained before bariatric surgery for patients and at any time before end of study for volunteers.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital
🇫🇷Nantes, France