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
  Purpose

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 Intervention
Obesity
Other: Digestive functions investigations

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810146

Contacts
Contact: Stanislas BRULEY DES VARANNES, Professor + 33 2 40 08 33 06 stanislas.bruleydesvarannes@chu-nantes.fr

Locations
France
University Hospital Recruiting
Nantes, France, 44000
Contact: Stanislas BRULEY DES VARANNES, Professor    +33 2 40 08 33 06    stanislas.bruleydesvarannes@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01810146     History of Changes
Other Study ID Numbers: RC12_0022
Study First Received: January 7, 2013
Last Updated: September 18, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on September 16, 2014