CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Evaluation of the endocannabinoid system +5 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01003873
NCT01003873N/ACompleted

Effect of Weight Loss Induced Either by Gastric Bypass or Lifestyle Intervention on the Peripheral Activity of the Endocannabinoid System

University Hospital, Bordeaux·observational·Posted Oct 29, 2009·Updated Oct 16, 2018

In Brief

An observational study evaluating Evaluation of the endocannabinoid system, Biopsy of visceral and peripheral adipose tissue, and 4 other interventions for Obesity. Completed, enrolled 44 participants across 1 site.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesFrance

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 29, 2009
Enrollment StartOct 1, 2009
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 16.7 years ago

Interventions

Evaluation of the endocannabinoid systembiological

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.

Biopsy of visceral and peripheral adipose tissueprocedure

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.

Evaluation of metabolic parametersbiological

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.

Evolution of behavioral parametersbehavioral

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

Dietician consultationbehavioral

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

Psychologist consultationbehavioral

The behavioural evaluation will de done with a psychologist consultation