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

NCT01810146 | Completed

• 1 other identifier: RC12_0022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (1)

Digestive functions investigations

NO INTERVENTION

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

Interventions

Digestive functions investigations OTHER

Digestive functions investigations

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

University Hospital

Nantes, 44000, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: March 13, 2013
• Study Start: September 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: November 21, 2014

Record last verified: 2014-11

Locations

FR (1)