Brown Adipose Tissue Clinical Trial
— NEXTOfficial 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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | August 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - BMI 18.5 to 25 kg/m2 or 30 to 35kg/m2 - Able to give informed consent as documented by signature - Age 18 to 40 years Exclusion Criteria: - Contraindications to glyceroltrinitrate, e.g. known hypersensitivity or allergy - Concomitant medication: Non-steroidal anti-inflammatory drugs (NSAID), glucocorticoids, diuretics, antihypertensives, fibrates or statins, metformin, PDE-5-inhibitors - Clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus) - Hypersensitivity to cold (e.g. Raynaud Syndrome) - Orthostatic hypotension: systolic blood pressure decreases min. 20mmHg or diastolic blood pressure decreases min 10mmHg within 3-5min after standing up (Schellong Test at screening visit) - History of orthostatic syncope or pre-syncope - Blood pressure values below 100 mmHg systolic and 60 mmHg diastolic - Allergy to local anesthetic - Hypothyroidism without sufficient substitution - Hyperthyroidism - Claustrophobia - Smoker / habitual tobacco use - Habitual excessive alcohol use - Weight change of >5% within 3 months prior to inclusion - Known or suspected non-compliance, drug or alcohol abuse - Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant - Enrolment of the investigator, his/her family members, employees and other dependent persons - Enrolment into another study using ionizing radiation within the previous 12 months - Pregnant or lactating women - Lab parameters - Hb below lower reference limit - Glycated Hemoglobin (HbA1c): above 6.0% - Random plasma glucose >11 mM |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Basel, Department of Endocrinology | Basel | BS |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Tissue biopsies of supraclavicular BAT and skeletal muscle musculus vastus lateralis | Analysis of the transcriptional changes both in BAT and muscle which are caused by the administration of glyceroltrinitrate (Nitroderm® TTS) as compared with no intervention | After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively | |
Primary | BAT SUVmean | 18F-FDG uptake into the supra-clavicular brown adipose tissue as determined by 18F- | After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively | |
Primary | BAT SUVmax | maximum SUV in supraclavicular adipose tissue (according to BARCIST 1.0) | After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively | |
Secondary | BAT Volume | volume of supraclavicular adipose tissue (according to BARCIST 1.0) | After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively | |
Secondary | BAT glycolytic volume | volume of supraclavicular adipose tissue x SUVmean (according to BARCIST 1.0) | After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively | |
Secondary | Energy expenditure | Quantitative change in EE above resting metabolic rate in response to the respective study intervention. Measured by indirect calorimetry. | After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively | |
Secondary | Cold induced thermogenesis | rise in energy expenditure above baseline occurring during mild cold exposure | After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively | |
Secondary | Mixed meal test | Changes in glucose tolerance and triglyceride levels after a mixed meal test in the respective study visit. | After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively | |
Secondary | Skin temperature | - Changes in skin temperature and body core temperature during treatment with glyceroltrinitrate (Nitroderm® TTS) compared to control. | After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02038595 -
The Norepinephrine Transporter: A Novel Target for Imaging Brown Adipose Tissue
|
Early Phase 1 | |
Completed |
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 |
NCT03095846 -
Cold Induced Activation of Brown Adipose Tissue in Winter Swimmers
|
N/A | |
Completed |
NCT03096535 -
Cold Induced Activation of Brown Adipose Tissue in Humans
|
N/A |