Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men

Study Overview
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Brief Summary
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Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in obese and normal-weight men subjects, to research a dysfunction in the negative feed-back between pregnenolone and CB1 ligand in obese subjects. This dysfunction could participate to the hyperactivity of endocannabinoid system saw in obesity.

Detailed Description
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Endocannabinoid system is an orexigenic key system, controlling the energy balance. It is composed of receptors (ex: CB1), of endogenous ligands, the endocannabinoids (ex: anandamide and 2- arachidonoylglycerol) and of enzymes implied in the synthesis and the degradation of the endocannabinoids. Researches resulting from our group highlighted anomalies of the plasmatic concentrations of endocannabinoid, in obese subject compared to normal-weight subject. Those being higher in obese subject with a flatness of post prandial reduction of AEA, so maintenance of elevated levels which can facilitate the food catch and create a metabolic vicious circle. In addition, prestigious research resulting from our collaborators highlighted in the animal that exposure to tetrahydrocannabinol (THC, ligand exogenic of CB1) induced the synthesis of pregnenolone (neurosteroid) which, by an autocrine effect on the CB1, inhibited the effects of the THC. In particular one of the principal behavioural effects: the food intake. We want to measure pregnenolone and endocannabinoid concentrations in men blood samples, to observe if this association exists in fasting conditions and over a meal in normal-weight and obese subjects. Obese subjects will be recruited during an hospitalization, while normal subject will be recruited by a poster at Bordeaux university and Haut-Leveque hospital. They will be included at Haut-Leveque hospital during morning at hospital.

Official Title
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Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men

Conditions
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Obesity

Intervention / Treatment
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* Other: Obese men
* Other: Normal-weight men


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obese subjects: men, aged between 18 and 65 years, BMI>30kg/m2. Normal-weight subjects: men, aged between 18 and 65 years, BMI<25kg/m2. Exclusion Criteria: For all subjects: cannabis detected by urinary tetrahydrocannabinol presence, treatment which can interfere with endocannabinoid system (antidepressant, antipsychotics, anxiolytics).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Obese men versus normal-weight men
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obese men<br>Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in obese men. | Other: Obese men<br>* Biological measures before, just before, and after lunch, in obese men<br>|
| Active Comparator: Normal-weight men<br>Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in normal-weight men. | Other: Normal-weight men<br>* Biological measures before, just before, and after lunch, in normal-weight men.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of pregnenolon plasmatic concentration in both groups. | Pregnenolon plasmatic concentration will be measured at several points. | Change from 1 hour before lunch to 1 hour after lunch at inclusion day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of neurosteroid plasma concentrations and endocannabinoid plasma concentrations | Neurosteroid and endocannabinoid plasma concentrations will be measured at several points. | Change from 1 hour before lunch to 1 hour after lunch at inclusion day | 
| Comparison of endocannabinoid plasma concentration and pregnenolone plasma concentration | Endocannabinoid and pregnenolone concentrations will be measured at several points. | Change from 1 hour before lunch to 1 hour after lunch at inclusion day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnenolone, endocannabinoid, food intake, type-1 cannabinoid receptor