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CannaPREG: Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Completed
CT.gov ID
NCT03157778
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France (Other)
25
Enrollment
1
Location
2
Arms
5.1
Actual Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Obese men
  • Other: Normal-weight men
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Obese men versus normal-weight menObese men versus normal-weight men
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men
Actual Study Start Date :
May 30, 2017
Actual Primary Completion Date :
Nov 2, 2017
Actual Study Completion Date :
Nov 2, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Obese men

Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in obese men.

Other: Obese men
Biological measures before, just before, and after lunch, in obese men
Active Comparator: Normal-weight men

Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in normal-weight men.

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

Outcome Measures

Primary Outcome Measures

  1. Comparison of pregnenolon plasmatic concentration in both groups. [Change from 1 hour before lunch to 1 hour after lunch at inclusion day]

    Pregnenolon plasmatic concentration will be measured at several points.

Secondary Outcome Measures

  1. Comparison of neurosteroid plasma concentrations and endocannabinoid plasma concentrations [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 [Change from 1 hour before lunch to 1 hour after lunch at inclusion day]

    Endocannabinoid and pregnenolone concentrations will be measured at several points.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Haut-Lévêque Pessac France 33600

Sponsors and Collaborators

  • University Hospital, Bordeaux
  • Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Study Chair: Lhomme Edouard, Dr, USMR

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT03157778
Other Study ID Numbers:
  • CHUBX 2015/33
First Posted:
May 17, 2017
Last Update Posted:
Jan 23, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Bordeaux
pregnenolone
endocannabinoid
food intake
type-1 cannabinoid receptor

Study Results

No Results Posted as of Jan 23, 2018