Nonalcoholic Fatty Liver DiseaseNCT07825467
Brown Adipose Tissue Activity and NAFLD Progression
An observational study of Nonalcoholic Fatty Liver Disease, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
This single-center, non-interventional observational study investigated the association between brown adipose tissue (BAT) activity and nonalcoholic fatty liver disease (NAFLD)-related clinical characteristics. Participants who had previously undergone clinically indicated 18F-FDG PET/CT examinations were enrolled. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2026to 5 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 to 80 years who had previously undergone 18F-FDG PET/CT examination for clinical purposes were recruited. Existing PET/CT imaging data were used to assess brown adipose tissue activity, and participants were categorized into high, intermediate, and low BAT activity groups according to BAT SUVmax. Peripheral blood samples and relevant clinical data were collected for analysis. No additional PET/CT examination was performed for research purposes.
Who may be able to join
- Patients who had undergone clinically indicated 18F-FDG PET/CT examination.
- Willing and able to provide written informed consent and comply with the study procedures.
- No long-term use of medications such as glucocorticoids or lipid-lowering drugs; no smoking or excessive alcohol consumption (alcohol intake <20 g/day).
- High BAT activity group: BAT SUVmax ≥2.0, with clear BAT activation in the cervical, shoulder, or supraclavicular regions on PET/CT.
- Intermediate BAT activity group: 1.0 ≤ BAT SUVmax <2.0.
- Low BAT activity group: BAT SUVmax <1.0 or no detectable BAT distribution on PET/CT.
Who cannot join
- Use of medications affecting metabolism within the previous 3 months, such as beta-blockers or thyroid hormones.
- Contraindications to PET/CT examination, such as claustrophobia or contrast-agent allergy.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Non-Interventional Clinical Study Investigating the Association Between Brown Adipose Tissue Activity and NAFLD Progression
This single-center, non-interventional observational study investigated the association between brown adipose tissue (BAT) activity and nonalcoholic fatty liver disease (NAFLD)-related clinical characteristics. Participants who had previously undergone clinically indicated 18F-FDG PET/CT examinations were enrolled. Existing PET/CT imaging data were collected and used to assess BAT activity.
Peripheral blood samples were collected for plasma analysis. The study aimed to identify circulating factors associated with BAT activity and to evaluate their relationships with NAFLD-related clinical and metabolic characteristics. No additional PET/CT examination, investigational treatment, or other therapeutic intervention was performed as part of this study.
Read the detailed description
This was a single-center, non-interventional observational study designed to investigate the relationship between brown adipose tissue (BAT) activity and NAFLD-related clinical and metabolic characteristics.
Participants who had already undergone 18F-FDG PET/CT examinations for clinical purposes were recruited. No additional PET/CT examination was performed for this study. Existing PET/CT imaging data were collected and analyzed to assess BAT activity. The maximum standardized uptake value (SUVmax) was used as an imaging parameter to evaluate BAT activity.
Peripheral blood samples were collected from participants for plasma analysis. Plasma samples were used to investigate circulating factors associated with BAT activity and their relationships with NAFLD-related clinical and metabolic parameters.
This study did not assign any investigational drug, device, behavioral intervention, or additional imaging examination. Only previously acquired PET/CT imaging data, peripheral blood samples, and relevant clinical information were collected and analyzed.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Keywords
- Brown Adipose Tissue, BAT Activity, 18F-FDG PET/CT, NAFLD, Plasma Proteomics
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High BAT Activity Group | Participants with high brown adipose tissue (BAT) activity, defined as BAT SUVmax ≥2.0 based on 18F-FDG PET/CT imaging data. | |
| Intermediate BAT Activity Group | Participants with intermediate brown adipose tissue (BAT) activity, defined as 1.0 ≤ BAT SUVmax <2.0 based on 18F-FDG PET/CT imaging data. | |
| Low BAT Activity Group | Participants with low brown adipose tissue (BAT) activity, defined as BAT SUVmax <1.0 or no detectable BAT activation based on 18F-FDG PET/CT imaging data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Differentially Abundant Plasma Proteins Across BAT Activity Group
Participants will be categorized into high, intermediate, and low brown adipose tissue (BAT) activity groups according to BAT SUVmax obtained from previously acquired clinical 18F-FDG PET/CT imaging data. Plasma protein abundance will be measured using label-free quantitative proteomics and expressed as normalized protein abundance. The outcome measure will be the number of plasma proteins meeting the prespecified statistical criteria for differential abundance among the three BAT activity groups.
Measured: At enrollment (single blood collection and assessment of previously acquired PET/CT data)
Secondary outcomes (1)
Number of Differentially Abundant Plasma Proteins Across BAT Activity Groups
Participants will be categorized into high, intermediate, and low brown adipose tissue (BAT) activity groups according to BAT SUVmax obtained from previously acquired clinical 18F-FDG PET/CT imaging data. Plasma protein abundance will be measured using label-free quantitative proteomics and expressed as normalized protein abundance. The outcome measure will be the number of plasma proteins meeting the prespecified statistical criteria for differential abundance among the three BAT activity groups.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start5 Jan 2026
- Primary completion5 Feb 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies 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
- Cross-sectional
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChenMingkai, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825467
- Sponsor's protocol ID
- WDRY2025-K343
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no prespecified IPD sharing plan was included in the approved study protocol, and the data are managed in accordance with institutional privacy and ethics requirements.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Non-Interventional Clinical Study Investigating the Association Between Brown Adipose Tissue Activity and NAFLD Progression
- ClinicalTrials.gov ID
- NCT07825467
- Acronym / sponsor ID
- WDRY2025-K343
- Conditions
- Nonalcoholic Fatty Liver Disease
- Keywords
- Brown Adipose Tissue, BAT Activity, 18F-FDG PET/CT, NAFLD, Plasma Proteomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 17 Sep 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 single-center, non-interventional observational study investigated the association between brown adipose tissue (BAT) activity and nonalcoholic fatty liver disease (NAFLD)-related clinical characteristics. Participants who had previously undergone clinically indicated 18F-FDG PET/CT examinations were enrolled. Existing PET/CT imaging data were collected and used to assess BAT activity.
Peripheral blood samples were collected for plasma analysis. The study aimed to identify circulating factors associated with BAT activity and to evaluate their relationships with NAFLD-related clinical and metabolic characteristics. No additional PET/CT examination, investigational treatment, or other therapeutic intervention was performed as part of this study.
Detailed description
This was a single-center, non-interventional observational study designed to investigate the relationship between brown adipose tissue (BAT) activity and NAFLD-related clinical and metabolic characteristics.
Participants who had already undergone 18F-FDG PET/CT examinations for clinical purposes were recruited. No additional PET/CT examination was performed for this study. Existing PET/CT imaging data were collected and analyzed to assess BAT activity. The maximum standardized uptake value (SUVmax) was used as an imaging parameter to evaluate BAT activity.
Peripheral blood samples were collected from participants for plasma analysis. Plasma samples were used to investigate circulating factors associated with BAT activity and their relationships with NAFLD-related clinical and metabolic parameters.
This study did not assign any investigational drug, device, behavioral intervention, or additional imaging examination. Only previously acquired PET/CT imaging data, peripheral blood samples, and relevant clinical information were collected and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High BAT Activity Group | – | –Participants with high brown adipose tissue (BAT) activity, defined as BAT SUVmax ≥2.0 based on 18F-FDG PET/CT imaging data. |
| Intermediate BAT Activity Group | – | –Participants with intermediate brown adipose tissue (BAT) activity, defined as 1.0 ≤ BAT SUVmax <2.0 based on 18F-FDG PET/CT imaging data. |
| Low BAT Activity Group | – | –Participants with low brown adipose tissue (BAT) activity, defined as BAT SUVmax <1.0 or no detectable BAT activation based on 18F-FDG PET/CT imaging data. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 to 80 years who had previously undergone 18F-FDG PET/CT examination for clinical purposes were recruited. Existing PET/CT imaging data were used to assess brown adipose tissue activity, and participants were categorized into high, intermediate, and low BAT activity groups according to BAT SUVmax. Peripheral blood samples and relevant clinical data were collected for analysis. No additional PET/CT examination was performed for research purposes.
Key inclusion criteria (6 listed)
- Patients who had undergone clinically indicated 18F-FDG PET/CT examination.
- Willing and able to provide written informed consent and comply with the study procedures.
- No long-term use of medications such as glucocorticoids or lipid-lowering drugs; no smoking or excessive alcohol consumption (alcohol intake <20 g/day).
- High BAT activity group: BAT SUVmax ≥2.0, with clear BAT activation in the cervical, shoulder, or supraclavicular regions on PET/CT.
- Intermediate BAT activity group: 1.0 ≤ BAT SUVmax <2.0.
Key exclusion criteria (3 listed)
- Use of medications affecting metabolism within the previous 3 months, such as beta-blockers or thyroid hormones.
- Contraindications to PET/CT examination, such as claustrophobia or contrast-agent allergy.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Differentially Abundant Plasma Proteins Across BAT Activity Group
Time frame: At enrollment (single blood collection and assessment of previously acquired PET/CT data)
Participants will be categorized into high, intermediate, and low brown adipose tissue (BAT) activity groups according to BAT SUVmax obtained from previously acquired clinical 18F-FDG PET/CT imaging data. Plasma protein abundance will be measured using label-free quantitative proteomics and expressed as normalized protein abundance. The outcome measure will be the number of plasma proteins meeting the prespecified statistical criteria for differential abundance among the three BAT activity groups.
1 secondary outcome
Number of Differentially Abundant Plasma Proteins Across BAT Activity Groups
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no prespecified IPD sharing plan was included in the approved study protocol, and the data are managed in accordance with institutional privacy and ethics requirements.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Nonalcoholic Fatty Liver Disease, run by Renmin Hospital of Wuhan University 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 17 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Differentially Abundant Plasma Proteins Across BAT Activity Group (time frame: At enrollment (single blood collection and assessment of previously acquired PET/CT data)). 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 17 Sep 2026.