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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01810146

Enrollment

Registered

2013-03-13

Start date

2012-09-30

Completion date

2014-03-31

Last updated

2014-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

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

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.

Interventions

OTHERDigestive functions investigations

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026