Brown Adipose Tissue, HumanBAT-PACTNCT07908719
A Multi-modal Cohort Study of Brown Adipose Tissue Based on Paired Comparisons at Room Temperature and After Cold Exposure
An observational study of Brown Adipose Tissue, Human, run by Jinling Hospital, China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Brown Adipose Tissue, Human
- What is being tested?
- cold exposure
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 31 Dec 2028
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- Aged 18 to 40 years, regardless of sex;
- Stable body weight within the past 3 months, with a weight change of < 3 kg;
- Able to tolerate the cold exposure test (without severe cold allergy, Raynaud's phenomenon, cold urticaria, or other related conditions).
Who cannot join
- Any diagnosed chronic metabolic disease (excluding diabetes mellitus and hyperlipidemia); no major organic diseases (including but not limited to cardiovascular, respiratory, endocrine, neuropsychiatric disorders) and no history of malignancy
- Pregnant women, breastfeeding women, or those planning to become pregnant during the study period;
- Use of β-blockers (e.g., propranolol), benzodiazepines (e.g., diazepam), or other medications that may affect brown adipose tissue metabolism (such as glucocorticoids, sympathomimetic agents, some antidepressants, etc.) within the past 4 weeks, as determined by the investigator;
- Presence of contraindications to PET-CT examination (e.g., claustrophobia, inability to remain supine for 30 minutes, allergy to FDG, etc.);
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu, 210002
Longjiang Zhang, MD, +8613405833167, kevinzhlj@163.com
Junhao Li, MD, +8615380874596, lijunhao1209@163.com
About this study
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.
Read the detailed description
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.
- Conditions
- Brown Adipose Tissue, Human
- Being tested
- cold exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold exposureOther
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).
| Study group | Role | What they receive |
|---|---|---|
| BAT-PAIR cohort | The participant will undergo PET-CT scanning under both room-temperature and post-cold-exposure conditions. Receives: Other: cold exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 2-hour cold exposure within 2 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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) .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brown Adipose Tissue, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang longjiang,MD, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908719
- Sponsor's protocol ID
- 2026DZKY-135-03
- Acronym
- BAT-PACT
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-modal Cohort Study of Brown Adipose Tissue Based on Paired Comparisons at Room Temperature and After Cold Exposure
- ClinicalTrials.gov ID
- NCT07908719
- Acronym / sponsor ID
- BAT-PACT / 2026DZKY-135-03
- Conditions
- Brown Adipose Tissue, Human
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAT-PAIR cohort | – | Other: cold exposureThe participant will undergo PET-CT scanning under both room-temperature and post-cold-exposure conditions. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Aged 18 to 40 years, regardless of sex;
- Stable body weight within the past 3 months, with a weight change of < 3 kg;
- Able to tolerate the cold exposure test (without severe cold allergy, Raynaud's phenomenon, cold urticaria, or other related conditions).
Key exclusion criteria (4 listed)
- Any diagnosed chronic metabolic disease (excluding diabetes mellitus and hyperlipidemia); no major organic diseases (including but not limited to cardiovascular, respiratory, endocrine, neuropsychiatric disorders) and no history of malignancy
- Pregnant women, breastfeeding women, or those planning to become pregnant during the study period;
- Use of β-blockers (e.g., propranolol), benzodiazepines (e.g., diazepam), or other medications that may affect brown adipose tissue metabolism (such as glucocorticoids, sympathomimetic agents, some antidepressants, etc.) within the past 4 weeks, as determined by the investigator;
- Presence of contraindications to PET-CT examination (e.g., claustrophobia, inability to remain supine for 30 minutes, allergy to FDG, etc.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cold exposureParticipants 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). | Other | BAT-PAIR cohort |
Primary outcome
brown adipose tissue at baseline
Time frame: Baseline at room-temperature
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.
brown adipose tissue at baseline
Time frame: Baseline at room-temperature
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.
brown adipose tissue at baseline
Time frame: Baseline at room-temperature
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.
brown adipose tissue after cold exposure
Time frame: After 2-hour cold exposure within 2 weeks
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.
brown adipose tissue after cold exposure
Time frame: After 2-hour cold exposure within 2 weeks
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.
brown adipose tissue after cold exposure
Time frame: After 2-hour cold exposure within 2 weeks
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.
8 secondary outcomes
Smoking history
Time frame: Baseline
Alcohol history
Time frame: baseline
Dietary habits
Time frame: baseline
Physical activity
Time frame: baseline
Life quality
Time frame: baseline
Anxiety
Time frame: baseline
Cognition
Time frame: baseline
Sleep quality
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brown Adipose Tissue, Human, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Longjiang Zhang, MD (+8613405833167, kevinzhlj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brown adipose tissue at baseline (time frame: Baseline at room-temperature). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.