An observational study in Brown Adipose Tissue, Human, sponsored by Jinling Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Jinling Hospital, China · Observational
This study is a single-center, prospective clinical study that plans to prospectively recruit volunteers aged 18-40 years, including metabolically healthy individuals and those with diabetes mellitus and hyperlipidemia. Participants will undergo [¹⁸F]fluorodeoxyglucose positron emission tomography/computed tomography ([¹⁸F]FDG PET/CT) scans both at room temperature and after cold exposure. The planned sample size is 500 participants. The study will systematically collect baseline data, questionnaire responses, [¹⁸F]FDG PET/CT images acquired under both conditions, as well as saliva and blood samples.
The study aims to establish a clinical-imaging-biological multimodal brown adipose tissue (BAT) cohort with paired pre- and post-cold exposure comparisons. Based on this cohort, we expect to achieve new breakthroughs in BAT detection methods, assessment criteria, and the understanding of its genetic mechanisms.
Brown adipose tissue (BAT) is a beneficial fat that expends energy through non-shivering thermogenesis and enhances metabolic health. It reduces serum cholesterol and triglyceride levels, attenuates atherosclerosis, and confers cardiovascular protection via endocrine pathways. While current clinical research predominantly focuses on the fully activated state following cold stimulation, human BAT remains in an unactivated or partially activated state for the majority of the time. Assessing BAT activity at room temperature, along with its potential activatable volume, may better reflect its physiological function under real-life conditions and provide superior predictive value for the prognosis of cardiometabolic diseases. Furthermore, inter-individual variability in BAT activity is collectively influenced by genetic, epigenetic, metabolic, and environmental factors. Owing to the lack of universally applicable detection modalities, establishing a large-scale, high-precision imaging-biological multimodal database remains challenging, which consequently constrains the screening of susceptibility genes and the discovery of serum protein biomarkers. This study aims to establish a clinical-imaging-biological multimodal BAT cohort with paired pre- and post-cold exposure comparisons. Using images from this cohort, we will train segmentation models capable of identifying BAT in both activated and resting states. Combined with participants' demographic information, dietary habits, physical activity, and other factors, we will explore the determinants of resting-state BAT activity and its potential activation capacity. By comparing saliva and blood samples collected at room temperature and after cold exposure, we will screen for BAT-related genetic loci and serum proteomic profiles.
In this study, participants will undergo [¹⁸F]fluorodeoxyglucose positron emission tomography/computed tomography ([¹⁸F]FDG PET/CT) scans both at room temperature and after cold exposure and systematically collect baseline data, questionnaire responses, [¹⁸F]FDG PET/CT images acquired under both conditions, as well as saliva and blood samples. Ultimately, based on this cohort, we expect to achieve new breakthroughs in BAT detection methods, assessment criteria, and the understanding of its genetic mechanisms.
Jinling Hospital, China is the lead sponsor of 131 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants aged 18-40 years who have no history of major diseases (such as tumors, endocrine disorders, etc., as determined by the investigator), have had stable weight over the past 3 months (weight change \< 3 kg), and have not taken β-blockers or benzodiazepines.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participant will undergo PET-CT scanning under both room-temperature and post-cold-exposure conditions.
Other: cold exposure
Participants will undergo saliva and blood collection and complete PET-CT scans both at room temperature and after cold exposure. The room-temperature PET-CT scan will be performed according to routine clinical protocols without the need for additional oral or injectable medications. For the post-cold-exposure scan, participants will only need to receive 2 hours of moderate cold exposure prior to the scan to adequately activate brown adipose tissue (they will be arranged to rest in a room maintained at 16-19 °C).
brown adipose tissue at baseline
The volume of brown adipose tissue at room-temperature. BAT was diagnosed on ¹⁸F-FDG PET-CT according to BARCIST 1.0, defined as areas with SUVbm ≥ 1.5 on PET and CT Hounsfield units between -190 and -10, after excluding obvious non-fat tissues within this range such as lung.
Time frame: Baseline at room-temperature
brown adipose tissue at baseline
The SUVmax of brown adipose tissue at room-temperature. BAT was diagnosed on ¹⁸F-FDG PET-CT according to BARCIST 1.0, defined as areas with SUVbm ≥ 1.5 on PET and CT Hounsfield units between -190 and -10, after excluding obvious non-fat tissues within this range such as lung.
Time frame: Baseline at room-temperature
brown adipose tissue at baseline
The SUVmean of brown adipose tissue at room-temperature. BAT was diagnosed on ¹⁸F-FDG PET-CT according to BARCIST 1.0, defined as areas with SUVbm ≥ 1.5 on PET and CT Hounsfield units between -190 and -10, after excluding obvious non-fat tissues within this range such as lung.
Time frame: Baseline at room-temperature
brown adipose tissue after cold exposure
The volume of brown adipose tissue after 2-hour cold exposure. BAT was diagnosed on ¹⁸F-FDG PET-CT according to BARCIST 1.0, defined as areas with SUVbm ≥ 1.5 on PET and CT Hounsfield units between -190 and -10, after excluding obvious non-fat tissues within this range such as lung.
Time frame: After 2-hour cold exposure within 2 weeks
brown adipose tissue after cold exposure
The SUVmax of brown adipose tissue after 2-hour cold exposure. BAT was diagnosed on ¹⁸F-FDG PET-CT according to BARCIST 1.0, defined as areas with SUVbm ≥ 1.5 on PET and CT Hounsfield units between -190 and -10, after excluding obvious non-fat tissues within this range such as lung.
Time frame: After 2-hour cold exposure within 2 weeks
brown adipose tissue after cold exposure
The SUVmean of brown adipose tissue after 2-hour cold exposure. BAT was diagnosed on ¹⁸F-FDG PET-CT according to BARCIST 1.0, defined as areas with SUVbm ≥ 1.5 on PET and CT Hounsfield units between -190 and -10, after excluding obvious non-fat tissues within this range such as lung.
Time frame: After 2-hour cold exposure within 2 weeks
Smoking history
Smoking history was assessed using a structured questionnaire that recorded current smoking status or former smoking, age at smoking initiation, and pack-years, calculated as cigarettes per day ÷ 20 × years of smoking.
Time frame: Baseline
Alcohol history
A structured alcohol history questionnaire was used to assess long-term drinking status, alcohol cessation, age at first drink, amount consumed per drinking occasion, and drinking patterns.
Time frame: baseline
Dietary habits
Dietary habits were assessed using the China Kadoorie Biobank (CKB) food frequency questionnaire (FFQ), which covers staple foods, vegetables, meat products, dairy products, preserved foods, and nuts, among other food groups.
Time frame: baseline
Physical activity
Physical activity was assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) , which asks about walking, moderate-intensity, and vigorous-intensity activity during the last 7 days. Total physical activity was expressed as MET-minutes per week and further categorized into low, moderate, or high levels according to the IPAQ scoring protocol.
Time frame: baseline
Life quality
Health-related quality of life was assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) . The instrument comprises a 5-dimension descriptive system (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on 5 levels (1 = no problems to 5 = extreme problems/unable to perform), and a visual analogue scale (EQ-VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health) .
Time frame: baseline
Anxiety
Anxiety was assessed using the Generalized Anxiety Disorder-7 (GAD-7) , a 7-item self-report scale. Each item is rated on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day), yielding a total score ranging from 0 to 21, with higher scores indicating greater anxiety severity. Scores of 5, 10, and 15 were used as cut-offs for mild, moderate, and severe anxiety, respectively.
Time frame: baseline
Cognition
Cognition was assessed using the Subjective Cognitive Decline Questionnaire-9 (SCD-Q9) , a 9-item self-report scale covering overall memory and temporal comparison (4 items) and daily activity ability (5 items) . Each item is scored 0 (no/never), 0.5 (occasionally), or 1 (yes/often), yielding a total score ranging from 0 to 9, with higher scores indicating more severe subjective cognitive decline. A score of ≥5 was used to define the presence of SCD.
Time frame: baseline
Sleep quality
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) , a 19-item self-report questionnaire covering the past month. The 19 items are grouped into seven components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction), each scored 0 (no difficulty) to 3 (severe difficulty) . The seven component scores are summed to yield a global score ranging from 0 to 21, with higher scores indicating worse sleep quality. A global score of \>7 was used to define poor sleep quality.
Time frame: baseline
Plan to share: No
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