Gastric Bypass and Peripheral Activity of the Endocannabinoid System

Completed

• Conditions: Obesity
• Interventions: Biological: Evaluation of the endocannabinoid system; Biological: Evaluation of metabolic parameters; Procedure: Biopsy of visceral and peripheral adipose tissue; Behavioral: Evolution of behavioral parameters; Behavioral: Psychologist consultation; Behavioral: Dietician consultation

• Registration Number: NCT01003873
• Lead Sponsor: University Hospital, Bordeaux

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

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-28
• Study First Posted: 2009-10-29
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bypass gastric	Evaluation of the endocannabinoid system	First arm is represented by obese patients that will be studied before and after a gastric bypass. They will be studied before surgery as well as 1 month and 6 months after surgery.
Lifestyle intervention	Psychologist consultation	The second group is represented by obese patients that will be studied before lifestyle intervention, 6 months after the beginning of the intervention and after a time that will allow patients to lose the same amount of weight that patients that had been through surgery had lost one month after surgery.
Bypass gastric	Dietician consultation	First arm is represented by obese patients that will be studied before and after a gastric bypass. They will be studied before surgery as well as 1 month and 6 months after surgery.
Lifestyle intervention	Evolution of behavioral parameters	The second group is represented by obese patients that will be studied before lifestyle intervention, 6 months after the beginning of the intervention and after a time that will allow patients to lose the same amount of weight that patients that had been through surgery had lost one month after surgery.
Bypass gastric	Evolution of behavioral parameters	First arm is represented by obese patients that will be studied before and after a gastric bypass. They will be studied before surgery as well as 1 month and 6 months after surgery.
Lifestyle intervention	Dietician consultation	The second group is represented by obese patients that will be studied before lifestyle intervention, 6 months after the beginning of the intervention and after a time that will allow patients to lose the same amount of weight that patients that had been through surgery had lost one month after surgery.
Control subjects	Evaluation of metabolic parameters	The third group is a control group of normal weight people that will be studied at one time and after 6 months with stable weight.
Bypass gastric	Biopsy of visceral and peripheral adipose tissue	First arm is represented by obese patients that will be studied before and after a gastric bypass. They will be studied before surgery as well as 1 month and 6 months after surgery.
Bypass gastric	Evaluation of metabolic parameters	First arm is represented by obese patients that will be studied before and after a gastric bypass. They will be studied before surgery as well as 1 month and 6 months after surgery.
Bypass gastric	Psychologist consultation	First arm is represented by obese patients that will be studied before and after a gastric bypass. They will be studied before surgery as well as 1 month and 6 months after surgery.
Lifestyle intervention	Evaluation of the endocannabinoid system	The second group is represented by obese patients that will be studied before lifestyle intervention, 6 months after the beginning of the intervention and after a time that will allow patients to lose the same amount of weight that patients that had been through surgery had lost one month after surgery.
Lifestyle intervention	Evaluation of metabolic parameters	The second group is represented by obese patients that will be studied before lifestyle intervention, 6 months after the beginning of the intervention and after a time that will allow patients to lose the same amount of weight that patients that had been through surgery had lost one month after surgery.
Control subjects	Evaluation of the endocannabinoid system	The third group is a control group of normal weight people that will be studied at one time and after 6 months with stable weight.
Control subjects	Evolution of behavioral parameters	The third group is a control group of normal weight people that will be studied at one time and after 6 months with stable weight.

Primary Outcome Measures

Name	Time	Method
Plasmatic endocannabinoïd concentration variation	Inclusion and 6 month-follow up

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of adipokines	At each visit
Body composition	At each visit
Plasma concentration of the endocannabinoids during food exposure	At each visit
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
Body mass index	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

Trial Locations

Locations (1)

Haut Lévêque Hospital, Endocrine department; 🇫🇷 Pessac, France