Skip to main content
OpenTrials
Completed

NCT Number: NCT03157778

Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Haut-Lévêque

Pessac, 33600, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Obese men

Other

Biological measures before, just before, and after lunch, in obese men

Normal-weight men

Other

Biological measures before, just before, and after lunch, in normal-weight men.

Primary outcomes

  1. Comparison of pregnenolon plasmatic concentration in both groups.

    Time frame: Change from 1 hour before lunch to 1 hour after lunch at inclusion day

    Pregnenolon plasmatic concentration will be measured at several points.

Secondary outcomes

  1. Comparison of neurosteroid plasma concentrations and endocannabinoid plasma concentrations

    Time frame: Change from 1 hour before lunch to 1 hour after lunch at inclusion day

    Neurosteroid and endocannabinoid plasma concentrations will be measured at several points.

  2. Comparison of endocannabinoid plasma concentration and pregnenolone plasma concentration

    Time frame: Change from 1 hour before lunch to 1 hour after lunch at inclusion day

    Endocannabinoid and pregnenolone concentrations will be measured at several points.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: CannaPREG

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 17, 2017
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.