Obesity
Conditions
Keywords
morbid obesity, bariatric surgery, lifestyle intervention, endocannabinoids system
Brief 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
Detailed description
Dysregulation of the endocannabinoid system has been associated with the development of obesity, metabolic and cardiovascular disorders in both animals and humans. Obese patients, especially those with abdominal obesity, have significantly higher levels of endocannabinoids. No influence of moderate (5%) body weight loss (induced either by diet intervention or sibutramine) on the peripheral activity of the endocannabinoid system gastric bypass (GB) surgery is the most efficient treatment of obesity Hormonal pathways may participate to the weight reducing effect of the procedure.The endocannabinoid system is present in the gastrointestinal tract. In animals, sustained weight loss after GB is characterized by reduction of endocannabinoids levels. The endocannabinoid levels will be studied (baseline and after stimulation) in: * Normal-weight subjects * Obese subjects before and after gastric bypass surgery * Obese subjects before and after a lifestyle intervention
Interventions
BIOLOGICALEvaluation 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.
PROCEDUREBiopsy 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.
BIOLOGICALEvaluation 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.
BEHAVIORALEvolution 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.
BEHAVIORALDietician consultation
The evaluation of the metabolic status will also be seen by a dietician.
BEHAVIORALPsychologist consultation
The behavioural evaluation will de done with a psychologist consultation
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Bordeaux
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Arms 1 and 2: * Age between 18 and 60 * BMI \> 40kg/m² or at least 30kg/m² with complication * Medical follow up before surgery * Patients that engaged themselves to a long medical follow up * Efficient contraception * Written, informed consent of each subject before the beginning of the study * Arm 3: * Age between 18 and 60 * BMI between 18 and 25 kg/m² * Stable weight over the 3 past months * Restrain score \<4 disinhibition \<6and hunger \> 4 at the TFEQ * No job in the endocrinology department * Written, informed consent of each subject before the beginning of the study
Exclusion criteria
* Arms 1,2 and 3 * No care of obesity before inclusion * Incapacity of the patient to follow a medical follow up * Drug or alcohol abuse * Urine test result positive for THC * Threaten life diseases * Pregnancy, breast feeding * Smoking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasmatic endocannabinoïd concentration variation | Inclusion and 6 month-follow up |
Secondary
| Measure | Time frame |
|---|---|
| Post prandial pic of the plasma concentration of the endocannabinoids | At each visit |
| Adipose tissue concentration of the endocannabinoids | Inclusion and 6 month-follow up |
| Plasma concentration of adipokines | At each visit |
| Body mass index | At each visit |
| Plasma concentration of the endocannabinoids during food exposure | At each visit |
| Insulin sensitivity | At each visit |
| Area under the curve of plasma concentration of 2AG | Inclusion and 6 month follow-up |
| Questionaries scores | At each visit |
| Body composition | At each visit |
Countries
France
Outcome results
None listed