University Hospital, Basel, Switzerland
The aim of this study is to evaluate the efficacy of glyceroltrinitrate (Nitroderm® TTS) to activate and expand human BAT as compared to mild cold exposure.
Brown Adipose Tissue
Glyceroltrinitrat
Early Phase 1
The activation of brown adipose tissue in response to glyceroltrinitrate as compared to cold exposure will be studied in an open-label, cross-over trial in healthy volunteers with random sequence of the two study periods (treatment and control) seperated by a washout period of 7 days. In the treatment phase all participants will receive Nitroderm® TTS (glyceroltrinitrate) for a total of 15 days. For better tolerability, it will be will started with a lower dose of 5mg/24h (Nitroderm® TTS) the first 5 days and after that a change to Nitroderm® TTS 10mg/24h for another 10 days will be done. Each transdermal patch will be applied for 12 hours per day (overnight) to avoid development of nitrate tolerance. Energy expenditure will be measured by indirect calorimetry before and after a mild cold exposure by placing a medical cooling system around their midsection. Additionally brown adipose tissue activity will determined by 18F-FDG-PET/CT 30 min after injection of 75 MBq of 18F-FDG. To analyse changes in BAT and muscle which are caused by glyceroltrinitrate as compared with cold stimulus, a tissue biopsie of supraclavicular BAT and skeletal muscle (musculus vastus lateralis) will be performed. To measure changes in glucose tolerance and triglyceride levels a mixed meal test will be performed during control and treatment phase respectively. Additionally, a indirect calorimetry will be conducted before and after mixed meal test to assess diet-induced thermogenesis, i.e. the increase in REE due to ingestion of nutrients In control phase the same examinations will be performed, but without glyceroltrinitrat.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 25 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Basic Science |
| Official Title : | Effect of Glyceroltrinitrate on Human Energy Expenditure and Brown Adipose Tissue Thermogenesis |
| Actual Study Start Date : | March 1, 2023 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | March 31, 2025 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: normal weight Treatment phase administration of glyceroltrinitrate (Nitroderm TTS) for 15 days. measurement of energy expenditure before and after cold exposure performing FDG-PET/CT and tissue biopsy (brown adipose tissue and muscle) measurement of glucose tolerance, triglyceride levels and energy expenditure before and after a mixed meal test. Control phase: measurement of energy expenditure before and after cold exposure performing FDG-PET/CT and tissue biopsy (brown adipose tissue and muscle) measurement of glucose tolerance, triglyceride levels and energy expenditure before and after a mixed meal test. |
Drug: Glyceroltrinitrat |
|
Experimental: overweight Treatment phase administration of glyceroltrinitrate (Nitroderm TTS) for 15 days. measurement of energy expenditure before and after cold exposure performing FDG-PET/CT and tissue biopsy (brown adipose tissue and muscle) measurement of glucose tolerance, triglyceride levels and energy expenditure before and after a mixed meal test. Control phase: measurement of energy expenditure before and after cold exposure performing FDG-PET/CT and tissue biopsy (brown adipose tissue and muscle) measurement of glucose tolerance, triglyceride levels and energy expenditure before and after a mixed meal test. |
Drug: Glyceroltrinitrat |
| Ages Eligible for Study: | 18 Years to 40 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
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Recruiting
University Hospital Basel, Department of Endocrinology
Basel, BS, Switzerland, 4031