Clinical trial NCT03157778: Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men
Official title: Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: pregnenolone
endocannabinoid
food intake
type-1 cannabinoid receptor
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2017-05-17
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Obese men versus normal-weight men
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Comparison of pregnenolon plasmatic concentration in both groups.
timeFrame: Change from 1 hour before lunch to 1 hour after lunch at inclusion day
Secondary outcomes:
measure: Comparison of neurosteroid plasma concentrations and endocannabinoid plasma concentrations
timeFrame: Change from 1 hour before lunch to 1 hour after lunch at inclusion day
measure: Comparison of endocannabinoid plasma concentration and pregnenolone plasma concentration
timeFrame: Change from 1 hour before lunch to 1 hour after lunch at inclusion day
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hôpital Haut-Lévêque
Study officials:
affiliation: USMR
name: Lhomme Edouard, Dr
role: STUDY_CHAIR
References: