Gastric Bypass and Peripheral Activity of the Endocannabinoid System

NCT01003873 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2018-10-16

No results posted yet for this study

Summary

The aim of the study is to precise the effect of a large amount of weight loss induced by gastric bypass on the endocannabinoid system (plasma and adipose tissue) of morbidly obese patients and to determine the influence of a gastric bypass surgery compared to a lifestyle intervention with equivalent weight loss on the endocannabinoid system

Conditions

Interventions

BIOLOGICAL

Evaluation of the endocannabinoid system

The evaluation of the endocannabinoid system consist in the determination of plasma concentration of the 2 main endocannabinoids (2AG and AEA) before (5 blood samples) and after (5 blood samples) after consumption of a calibrated food. As a comparator, ghrelin will be measured at the same time.

PROCEDURE

Biopsy of visceral and peripheral adipose tissue

The endocannabinoids will be also determined in adipose tissue. Biopsy of visceral and peripheral adipose tissue will be done during surgery and peripheral adipose tissue will be done 6 months after surgery.

BIOLOGICAL

Evaluation of metabolic parameters

The evaluation of the metabolic status consist in evaluation of body composition (DEXA), determination of visceral adiposity (CT scan) and measurement of plasma lipids, glucose, insulin, leptin, adiponectin.

BEHAVIORAL

Evolution of behavioral parameters

The behavioral evaluation will de done with different questionnaires: ORWELL 97, HAD scale, Three Factor Eating Questionnaire, Beck Depression inventory, Questionnaire of personality TCI.

BEHAVIORAL

Dietician consultation

The evaluation of the metabolic status will also be seen by a dietician.

BEHAVIORAL

Psychologist consultation

The behavioural evaluation will de done with a psychologist consultation

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV
  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Blandine GATTA-CHERIFI, MD · University Hospital, Bordeaux, France

  • Antoine BENARD, MD · University Hospital, Bordeaux, France

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01003873 on ClinicalTrials.gov