Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-30

Study Completion Date

2017-11-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Saliva and Plasma Endocannabinoids Concentrations According to Feeding Status and Body Mass Index

NCT01223157

Obesity

COMPLETED NA

Pleasure for Food and Endocannabinoids in Obesity

NCT01985139

Obesity

COMPLETED NA

The Effects of Energy Imbalance on Food Intake Behaviors

NCT03112161

Obesity

COMPLETED NA

Implications of Circadian Variation of Human Endocannabinoid Levels on Obesity Risk

NCT03000803

Obesity

WITHDRAWN NA

CBD, Nutrient Metabolism and Energy Intake

NCT05618756

Glucose Metabolism Disorders (Including Diabetes Mellitus) Lipid Metabolism Disorders Appetitive Behavior

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Obese men versus normal-weight men

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Obese men

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

Group Type EXPERIMENTAL

Obese men

Intervention Type OTHER

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

Normal-weight men

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

Group Type ACTIVE_COMPARATOR

Normal-weight men

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Obese men

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

Intervention Type OTHER

Normal-weight men

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No