Effect of glycerol trinitrate (Nitroderm® TTS) on heat production by brown adipose tissue in humans.
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
- 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)
Luogo dello studio
Basilea
(BASEC)
Sponsor
PD Dr. med. Matthias J. Betz
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
PD Dr. med. Matthias J. Betz
+41615565654
matthias.betz@clutterusb.chUniversity hospital Basel, Department of Endokrinology, Diabetology Petersgraben 4, 4031 Basel
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
03.01.2023
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Effect of Glyceroltrinitrate on human energy expenditure an brown adipose tissue thermogenesis. - The NEXT Trial. (BASEC)
Titolo accademico
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Endpoint primari e secondari
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Risultati dello studio
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