Gastric Bypass and Peripheral Activity of the Endocannabinoid System
NCT ID: NCT01003873
Last Updated: 2018-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
44 participants
OBSERVATIONAL
2009-10-31
2014-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
Dietician consultation
The evaluation of the metabolic status will also be seen by a dietician.
Psychologist consultation
The behavioural evaluation will de done with a 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.
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.
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.
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.
Dietician consultation
The evaluation of the metabolic status will also be seen by a dietician.
Psychologist consultation
The behavioural evaluation will de done with a 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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
Dietician consultation
The evaluation of the metabolic status will also be seen by a dietician.
Psychologist consultation
The behavioural evaluation will de done with a psychologist consultation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Blandine GATTA-CHERIFI, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux, France
Antoine BENARD, MD
Role: STUDY_CHAIR
University Hospital, Bordeaux, France
Locations
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Haut Lévêque Hospital, Endocrine department
Pessac, , France
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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CHUBX 2008/19
Identifier Type: -
Identifier Source: org_study_id
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