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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01810146
First received: January 7, 2013
Last updated: September 18, 2013
Last verified: March 2013

January 7, 2013
September 18, 2013
September 2012
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01810146 on ClinicalTrials.gov Archive Site
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Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders (EnteroNeurObesity)
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.

Not Provided
Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Obesity
Other: Digestive functions investigations
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).
Intervention: Other: Digestive functions investigations
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
March 2015
March 2014   (final data collection date for primary outcome measure)

Patients:

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:

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

Both
18 Years to 65 Years
Yes
Contact: Stanislas BRULEY DES VARANNES, Professor + 33 2 40 08 33 06 stanislas.bruleydesvarannes@chu-nantes.fr
France
 
NCT01810146
RC12_0022
Not Provided
Nantes University Hospital
Nantes University Hospital
Not Provided
Not Provided
Nantes University Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP