Clinical trial NCT01223157: Saliva and Plasma Endocannabinoids Concentrations According to Feeding Status and Body Mass Index
Official title: Saliva and Plasma Endocannabinoids Concentrations According to Feeding Status and Body Mass Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
endocannabinoids
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2010-10-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Up till now, the evaluation of the endocannabinoid system (ECS) in humans needs invasive procedures. The investigators managed in the lab to determine the levels of endocannabinoids in a small number of subjects. The aim of the study is to confirm that salivary is a useful tool to evaluate the activity of the ECS both in normal weight and obese subjects that are characterised by a hyperactivity of the system. Therefore, the first objective of the study is to compare the fasting level of salivary anandamide between 12 obese patients and 12 normal weight subjects.

Detailed description: The prevalence of obesity keeps increasing in industrialized countries. However, efficient treatments of this chronic disease are still lacking. A better understanding of the systems that regulate energy balance and eating behavior is mandatory to better understand the disease and find appropriate treatments. The endocannabinoid system (ECS) which comprises cannabinoid receptors, such as CB1 and CB2, endogenous ligands (named endocannabinoids) and specific biosynthetic and degradative pathways is a key system in the regulation of energy balance and obesity. Obesity is characterised by an hyperactivity of the system both in animal and humans. Moreover, the activity of the ECS is influenced by feeding status although only one study has only been performed in humans. The investigation of the ECS in humans needs invasive procedure (blood sampling or adipose or liver biopsy). The aim of our study is to evaluate a new tool for the ECS evaluation in humans i e the determinations of saliva concentration of endocannabinoids both in normal weight and obese subjects before and after food intake. Blood and saliva sampling will be performed after an overnight fast, one hour before, just before and one hour after a lunch in12 normal weight subjects and 12 obese characterised with anthropometric (Weight, height, BMI (Body Mass Index), waist circumference, blood pressure) and metabolic (glycaemia, insulin, lipid profile, liver profile) evaluations. The endocannabinoids concentrations will be measured with mass spectrometry in blood and saliva and gut hormones (PYY (peptide YY) and ghrelin) will be measured in plasma.

Eligibility criteria: Inclusion Criteria:

Obese patients :

* Age between 18 and 65 yrs
* BMI (Body Mass Index) \> 30 kg/m²
* Signed inform Consent before any investigation related to the study
* No smoker

Normal weight subjects :

* Age between 18 and 65 yrs
* BMI between 18 and 25 kg/m²
* Signed inform Consent before any investigation related to the study
* No smoker

Exclusion Criteria:

* treatments that could interfere with the endocannabinoid system (anxiolytics, anticonvulsivants, antidepressants drugs)
* pregnancy, breast feeding

Primary outcomes:
measure: Anandamide(AEA)concentration
timeFrame: Saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
Secondary outcomes:
measure: 2-AG( 2 arachidonoylglycerol), OEA (oleoylethanolamide), PEA (palmitoyléthanolamide) concentrations
timeFrame: Saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
measure: Food intake influence on saliva endocannabinoids
timeFrame: Saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
measure: Plasma endocannabinoids level
timeFrame: Blood sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
measure: Correlation between saliva and plasma endocannabinoids
timeFrame: Blood and saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
measure: Relationship between saliva or plasma endocannabinoids and gut hormones
timeFrame: Blood and saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service of Endocrinology, Diabetology, metabolic diseases - Hôpital du Haut Lévêque - CHU de BORDEAUX
Study officials:
affiliation: University Hospital, Bordeaux
name: Blandine GATTA, Dr
role: PRINCIPAL_INVESTIGATOR
References: