Brown Adipose Tissue Clinical Trial
Official title:
Effect of Glyceroltrinitrate on Human Energy Expenditure and Brown Adipose Tissue Thermogenesis
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02038595 -
The Norepinephrine Transporter: A Novel Target for Imaging Brown Adipose Tissue
|
Early Phase 1 | |
| Active, not recruiting |
NCT02964442 -
Brown Adipose Tissue Activation and Energy Expenditure by Capsinoids Stimulation With Trimodality Imaging Using 18-FDG-PET, Fat Fraction MRI and Infrared Thermography
|
N/A | |
| Recruiting |
NCT06078345 -
Brown Adipose Tissue as Nutrient Buffer Through Diet Induced Thermogenesis
|
N/A | |
| Active, not recruiting |
NCT03541096 -
Winter-Swimming and Brown Adipose Tissue Activity in Middel-aged Obese Subjects (WinterBAT).
|
N/A | |
| Completed |
NCT04766021 -
Mirabegron and Physiological Function in Cold Environments
|
Phase 1/Phase 2 | |
| Completed |
NCT01898949 -
Stimulation of Diet-Induced Thermogenesis by Cold-Exposure
|
N/A | |
| Completed |
NCT05990387 -
MIrabegron and Physiological Function in Cold Environments
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04595006 -
Brown Fat Activation and Browning Efficiency Augmented by Chronic Cold and Nutraceuticals for Brown Adipose Tissue-mediated Effect Against Metabolic Syndrome (BEACON BEAMS Study)
|
N/A | |
| Completed |
NCT02381483 -
Vitamin A in Brown Fat Activity
|
N/A | |
| Completed |
NCT03269747 -
Short Term Effect of Glucocorticoids on Brown Adipose Tissue Thermogenesis in Humans
|
Phase 4 | |
| Recruiting |
NCT05517967 -
An Examination of Brown Adipose Tissue and Energy Expenditure in Infants
|
||
| Completed |
NCT03490227 -
Measurement of Body Fat in Infants
|
||
| Completed |
NCT03096535 -
Cold Induced Activation of Brown Adipose Tissue in Humans
|
N/A | |
| Completed |
NCT03095846 -
Cold Induced Activation of Brown Adipose Tissue in Winter Swimmers
|
N/A |