- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02941172
CB1 Receptors in Human Brown Adipose Tissue (CANBAT)
Cannabinoid CB1 Receptors in Human Brown Adipose Tissue
This study investigates cannabinoid CB1 receptors in human brown adipose tissue (BAT) and other tissues using positron emission tomography (PET) imaging. Subjects will be scanned in room temperature conditions and during controlled cold exposure, and the density of CB1 receptors in BAT and other tissues will be quantified. The investigators hypothesize, that cannabinoid signaling is increased in cold conditions, when BAT is metabolically active.
Understanding the mechanisms of BAT activation and the role of endocannabinoids in humans is important and beneficial in fighting against the epidemic of obesity and diabetes.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Endocannabinoids have an important role in regulating energy balance and metabolism. Cannabinoid 1 receptors (CB1) are found in several tissues such as brown adipose tissue (BAT). Endocannabinoids and CB1 receptors participate in the control of lipid and glucose metabolism, and blockage of CB1 receptors has been found to improve metabolic factors linked to obesity and cardiovascular disease, making CB1 antagonists potential drugs against obesity and diabetes.
In this study the investigators use a PET radiotracer [18F]FMPEP-d2, which binds to CB1 receptors in vivo, to quantify the CB1 receptor density in BAT, white adipose tissue, muscle and the brain. This study is done once in warm conditions and once during controlled cold exposure. To verify whether the subject has metabolically active BAT, an additional PET scan with the radiotracer [18F]FDG is performed.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Turku, Finlande, 20521
- Turku PET Centre (Turku University Hospital)
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Healthy volunteer
- Group 1: BMI 20-26 kg/m2, Group2: BMI 27-40 kg/m2
Exclusion Criteria:
- BMI < 20 kg/m2or BMI > 40 kg/m2
- Any chronic disease that could affect the study outcome, including medicated type 2 diabetes
- Mental disorder or poor compliance
- Eating disorder or excessive use of alcohol, tobacco smoking or drug use
- Past dose of radiation
- Presence of any ferromagnetic objects that would make MR imaging contraindicated
- Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: [18F]FMPEP-d2 in warm conditions
PET scan is performed using PET radiotracer [18F]FMPEP-d2 in standard room temperature conditions.
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PET radiotracer used in imaging
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Autre: [18F]FMPEP-d2 in cold conditions
PET scan is performed using PET radiotracer [18F]FMPEP-d2 during controlled cold exposure.
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PET radiotracer used in imaging
Controlled cold exposure is performed before and during PET scan
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Autre: [18F]FDG in cold conditions
PET scan is performed using PET radiotracer [18F]FDG during controlled cold exposure.
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Controlled cold exposure is performed before and during PET scan
PET radiotracer used in imaging
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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CB1 density of brown adipose tissue acquired with PET
Délai: within one study day
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PET imaging is used to quantify CB1 receptors in tissues
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within one study day
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Glucose uptake of brown adipose tissue acquired with PET
Délai: within one study day
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PET imaging is used to quantify glucose uptake in tissues
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within one study day
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 42/2014
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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