Back to resultsCharacterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders (EnteroNeurObesity)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Digestive functions investigations
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring Patients eligible for bariatric surgery (BMI>40kg/m2)
Eligibility Criteria
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.
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Digestive functions investigations
Arm Description
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).
Outcomes
Primary Outcome Measures
T1/2 solids (on the kinetic of isotopic gastric empty exam)
This evaluation will be obtained before bariatric surgery for patients and at any time before end of study for volunteers.
Secondary Outcome Measures
Full Information
NCT ID
NCT01810146
First Posted
January 7, 2013
Last Updated
November 20, 2014
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01810146
Brief Title
Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders (EnteroNeurObesity)
Official Title
Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders(EnteroNeurObesity)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Patients eligible for bariatric surgery (BMI>40kg/m2)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Digestive functions investigations
Arm Type
No Intervention
Arm Description
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 Type
Other
Intervention Name(s)
Digestive functions investigations
Primary Outcome Measure Information:
Title
T1/2 solids (on the kinetic of isotopic gastric empty exam)
Description
This evaluation will be obtained before bariatric surgery for patients and at any time before end of study for volunteers.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University Hospital
City
Nantes
ZIP/Postal Code
44000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders (EnteroNeurObesity)
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