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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasmatic endocannabinoïd concentration variation | Inclusion and 6 month-follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of the endocannabinoids during food exposure | At each visit | |
| Post prandial pic of the plasma concentration of the endocannabinoids | At each visit | |
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Inclusion Criteria:
Exclusion Criteria:
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2 groups : from primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Blandine GATTA-CHERIFI, MD | University Hospital, Bordeaux, France | Principal Investigator |
| Antoine BENARD, MD | University Hospital, Bordeaux, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haut Lévêque Hospital, Endocrine department | Pessac | 33600 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15856067 | Background | 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. | |
| 17683024 | 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. |
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Biopsy of visceral and peripheral adipose tissue will be done during surgery and peripheral adipose tissue will be done 6 months after surgery
|
| 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. |
|
| 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. |
|
| 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. |
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| Dietician consultation | Behavioral | The evaluation of the metabolic status will also be seen by a dietician. |
|
| Psychologist consultation | Behavioral | The behavioural evaluation will de done with a psychologist consultation |
|
| 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 |
| Body composition | 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 |
| 16186383 | 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. |
| 17065342 | 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. |
| 17715408 | 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. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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