Gastric Bypass and Peripheral Activity of the Endocannabinoid System

NCT01003873 | Completed

• 1 other identifier: CHUBX 2008/19
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Keywords

morbid obesity; bariatric surgery; lifestyle intervention; endocannabinoids system

Outcome Measures

Primary Outcomes (1)

• Plasmatic endocannabinoïd concentration variation

  Inclusion and 6 month-follow up

Secondary Outcomes (9)

• 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

• Plasma concentration of adipokines

  At each visit

• Body mass index

  At each visit

Study Arms (3)

Bypass gastric

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.

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

Lifestyle intervention

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.

Biological: Evaluation of the endocannabinoid system; Biological: Evaluation of metabolic parameters; Behavioral: Evolution of behavioral parameters; Behavioral: Dietician consultation; Behavioral: Psychologist consultation

Control subjects

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.

Biological: Evaluation of the endocannabinoid system; Biological: Evaluation of metabolic parameters; Behavioral: Evolution of behavioral parameters

Interventions

Evaluation of the endocannabinoid system BIOLOGICAL

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.

Bypass gastric; Control subjects; Lifestyle intervention

Biopsy of visceral and peripheral adipose tissue PROCEDURE

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.

Bypass gastric

Evaluation of metabolic parameters BIOLOGICAL

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.

Bypass gastric; Control subjects; Lifestyle intervention

Evolution of behavioral parameters BEHAVIORAL

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

Bypass gastric; Control subjects; Lifestyle intervention

Dietician consultation BEHAVIORAL

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

Bypass gastric; Lifestyle intervention

Psychologist consultation BEHAVIORAL

The behavioural evaluation will de done with a psychologist consultation

Bypass gastric; Lifestyle intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

2 groups : from primary care clinic * obese patients with gastric bypass * obese patients with lifestyle intervention 1 group : volunteer

You may qualify if:

• 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

You may not qualify if:

• Arms 1,2 and 3
• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Haut Lévêque Hospital, Endocrine department

Pessac, 33600, France

Location

Related Publications (5)

• Di Marzo V, Matias I. Endocannabinoid control of food intake and energy balance. Nat Neurosci. 2005 May;8(5):585-9. doi: 10.1038/nn1457.

  PMID: 15856067 BACKGROUND

• Cota D. CB1 receptors: emerging evidence for central and peripheral mechanisms that regulate energy balance, metabolism, and cardiovascular health. Diabetes Metab Res Rev. 2007 Oct;23(7):507-17. doi: 10.1002/dmrr.764.

  PMID: 17683024 BACKGROUND

• Engeli S, Bohnke J, Feldpausch M, Gorzelniak K, Janke J, Batkai S, Pacher P, Harvey-White J, Luft FC, Sharma AM, Jordan J. Activation of the peripheral endocannabinoid system in human obesity. Diabetes. 2005 Oct;54(10):2838-43. doi: 10.2337/diabetes.54.10.2838.

  PMID: 16186383 BACKGROUND

• Bluher M, Engeli S, Kloting N, Berndt J, Fasshauer M, Batkai S, Pacher P, Schon MR, Jordan J, Stumvoll M. Dysregulation of the peripheral and adipose tissue endocannabinoid system in human abdominal obesity. Diabetes. 2006 Nov;55(11):3053-60. doi: 10.2337/db06-0812.

  PMID: 17065342 BACKGROUND

• Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.

  PMID: 17715408 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy of visceral and peripheral adipose tissue will be done during surgery and peripheral adipose tissue will be done 6 months after surgery

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

• Blandine GATTA-CHERIFI, MD

  University Hospital, Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Antoine BENARD, MD

  University Hospital, Bordeaux, France

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2009
• First Posted: October 29, 2009
• Study Start: October 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

FR (1)