Effect of glycerol trinitrate (Nitroderm® TTS) on heat production by brown adipose tissue in humans.
Résumé de l'étude
In our study, we want to find out whether brown adipose tissue in humans can be activated by the drug glycerol trinitrate (Nitroderm® TTS), a drug that has already been successfully used in the treatment of heart diseases, to a similar extent as it occurs through cold stimulation.
(BASEC)
Intervention étudiée
30 healthy volunteers will be included in the study. The study will proceed in 2 phases; in the first phase (medication phase), the participant will receive the drug glycerol trinitrate (Nitroderm® TTS) for 15 days. Subsequently, energy expenditure will be measured using indirect calorimetry and a quantitative determination of brown adipose tissue will be performed using FDG-PET/CT. A small tissue sample from muscle and adipose tissue will then be taken. Additionally, at another study visit, glucose and fat uptake in the blood will be measured after administration of a standardized liquid meal (Mixed Meal Test). The glycerol trinitrate (Nitroderm® TTS) will then be stopped and after a 1-week break, the same study examinations will be repeated (control phase).
(BASEC)
Maladie en cours d'investigation
Brown adipose tissue in humans.
(BASEC)
- Healthy volunteers aged between 18-40 years - BMI between 18.5-23 kg/m2, or between 30-35 kg/m2 - Participants must be able to give and document informed consent (by signature) (BASEC)
Critères d'exclusion
- Contraindication for glycerol trinitrate - Regular medication intake - Clinically significant comorbidities - Hypersensitivity to cold - Orthostatic hypotension (low blood pressure), syncope, pre-syncope - Allergy to local anesthetics - Thyroid over- or under-function - Regular alcohol or nicotine consumption - Inability to follow the study protocol (linguistic, psychological, etc.) - Inclusion in another study with ionizing radiation within the last 12 months - Pregnant or breastfeeding women - Laboratory values: low hemoglobin (red blood cells), elevated HbA1c (long-term sugar) or elevated blood sugar (BASEC)
Lieu de l’étude
Bâle
(BASEC)
Sponsor
PD Dr. med. Matthias J. Betz
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
PD Dr. med. Matthias J. Betz
+41615565654
matthias.betz@clutterusb.chUniversity hospital Basel, Department of Endokrinology, Diabetology Petersgraben 4, 4031 Basel
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
03.01.2023
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
Effect of Glyceroltrinitrate on human energy expenditure an brown adipose tissue thermogenesis. - The NEXT Trial. (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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