Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men

Obesity Clinical Trial

— CannaPREG  

Official title:

Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157778
• Other study ID #: CHUBX 2015/33
• Status: Completed
• Phase: N/A
• First received: May 5, 2017
• Last updated: January 19, 2018
• Start date: May 30, 2017
• Est. completion date: November 2, 2017

Study information

• Verified date: January 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2, 2017
• Est. primary completion date: November 2, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Obese men
Biological measures before, just before, and after lunch, in obese men
• Normal-weight men
Biological measures before, just before, and after lunch, in normal-weight men.

Locations

Country	Name	City	State
France	Hôpital Haut-Lévêque	Pessac

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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