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

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01810146

Collaborator

(none)

Enrollment

Location

Arm

17.9

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Digestive functions investigations	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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)

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Nantes		France	44000

Sponsors and Collaborators

Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT01810146

Other Study ID Numbers:

RC12_0022

First Posted:

Mar 13, 2013

Last Update Posted:

Nov 21, 2014

Last Verified:

Nov 1, 2014

Keywords provided by Nantes University Hospital

Patients eligible for bariatric surgery (BMI>40kg/m2)

Additional relevant MeSH terms:

Obesity

Metabolic Diseases

Study Results

No Results Posted as of Nov 21, 2014