Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men
CannaPREG
2 other identifiers
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started May 2017
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedStudy Start
First participant enrolled
May 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2017
CompletedMay 22, 2026
January 1, 2018
5 months
May 5, 2017
May 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Comparison of neurosteroid plasma concentrations and endocannabinoid plasma concentrations
Change from 1 hour before lunch to 1 hour after lunch at inclusion day
Comparison of endocannabinoid plasma concentration and pregnenolone plasma concentration
Change from 1 hour before lunch to 1 hour after lunch at inclusion day
Study Arms (2)
Obese men
EXPERIMENTALMeasured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in obese men.
Normal-weight men
ACTIVE COMPARATORMeasured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in normal-weight men.
Interventions
Biological measures before, just before, and after lunch, in normal-weight men.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- For all subjects:
- cannabis detected by urinary tetrahydrocannabinol presence,
- treatment which can interfere with endocannabinoid system (antidepressant, antipsychotics, anxiolytics).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Haut-Lévêque
Pessac, 33600, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lhomme Edouard, Dr
USMR
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2017
First Posted
May 17, 2017
Study Start
May 30, 2017
Primary Completion
November 2, 2017
Study Completion
November 2, 2017
Last Updated
May 22, 2026
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share