Effect of glycerol trinitrate (Nitroderm® TTS) on heat production by brown adipose tissue in humans.
Summary description of the study
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 under investigation
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)
Disease under 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)
Exclusion criteria
- 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)
Trial sites
Basel
(BASEC)
Sponsor
PD Dr. med. Matthias J. Betz
(BASEC)
Contact
Contact Person Switzerland
PD Dr. med. Matthias J. Betz
+41615565654
matthias.betz@clutterusb.chUniversity hospital Basel, Department of Endokrinology, Diabetology Petersgraben 4, 4031 Basel
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
03.01.2023
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Effect of Glyceroltrinitrate on human energy expenditure an brown adipose tissue thermogenesis. - The NEXT Trial. (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available