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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01810146
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):

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
Obesity Other: Digestive functions investigations

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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 : September 2012
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. T1/2 solids (on the kinetic of isotopic gastric empty exam) [ Time Frame: 6 months ]
    This evaluation will be obtained before bariatric surgery for patients and at any time before end of study for volunteers.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810146


Locations
France
University Hospital
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital
More Information

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01810146     History of Changes
Other Study ID Numbers: RC12_0022
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014

Keywords provided by Nantes University Hospital:
Patients eligible for bariatric surgery (BMI>40kg/m2)

Additional relevant MeSH terms:
Obesity
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms