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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Nantes, 44000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digestive functions investigations

Other

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Mar 13, 2013
Registry last updated: Nov 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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