Insulin ResistanceNCT07327684
Photoacoustic/Ultrasound Imaging of Brown Adipose Tissue Activity
A study testing Multi-wavelength PA/US imaging scanning and cold exposure in people with Insulin Resistance and Metabolic Syndrome, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this study is to develop a novel, non-invasive, real-time photoacoustic imaging (PAI) technology for quantifying brown adipose tissue (BAT) and to investigate the differences in BAT morphology and metabolic function between healthy individuals and patients with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Metabolic Syndrome
- What is being tested?
- Multi-wavelength PA/US imaging scanning and cold exposure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2025to 31 Dec 2027
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Criteria for Healthy Subjects:
(INCLUSION CRITERIA)
- Healthy individuals over 18 years of age.
- Body Mass Index (BMI) < 30.
- No history of metabolic diseases, rheumatic immune diseases, or cardiovascular and cerebrovascular diseases.
- Not currently using any sympathomimetic or sympatholytic drugs.
- Non-smoker and does not consume excessive alcohol. (EXCLUSION CRITERIA)
- Weight change > 5% within 3 months prior to enrollment.
- BMI ≥ 30.
- Diagnosis of metabolic disease, rheumatic immune disease, cardiovascular and cerebrovascular disease, or malignant tumor.
- Use of sympathomimetic or sympatholytic drugs within 3 months prior to enrollment.
- Smoker or consumes excessive alcohol.
- Diagnosis of Raynaud's disease, or intolerance/allergy to cold stimulation.
- Currently pregnant, lactating, or menstruating.
- Contraindications to the injection of the radionuclide tracer Fluorodeoxyglucose (18F-FDG) or other conditions unsuitable for PET-CT examination.
Criteria for Patients with Metabolic Syndrome and Insulin Resistance-Related Diseases:
(INCLUSION CRITERIA)
- Age between 18 and 60 years.
- Must meet 3 or more of the following criteria:
- Waist circumference ≥ 90 cm for males, ≥ 85 cm for females.
- Fasting blood glucose ≥ 6.10 mmol/L (110 mg/dl) OR 2-hour postprandial blood glucose ≥ 7.80 mmol/L (140 mg/dl) OR previously diagnosed diabetes.
- Blood pressure ≥ 130/85 mmHg OR previously diagnosed hypertension and under treatment.
- Fasting triglycerides (TG) ≥ 1.7 mmol/L (150 mg/dl).
- Fasting high-density lipoprotein cholesterol (HDL-C) < 1.0 mmol/L (40 mg/dl).
- Patients diagnosed with Polycystic Ovary Syndrome (PCOS), defined as meeting two or more of the following criteria and excluding other endocrine diseases that could cause similar symptoms: hyperandrogenism, ovulatory dysfunction, polycystic ovary morphology. (EXCLUSION CRITERIA)
- Diagnosis of Type 1 diabetes or other specific types of diabetes.
- Presence of acute diabetic complications or severe chronic diabetic complications.
- History of acute or chronic pancreatitis, or pancreatic tumors.
- Heart failure, unstable angina, myocardial infarction within the past 12 months, cerebral infarction, severe arrhythmia, or severe hypertension (blood pressure > 180/110 mmHg despite antihypertensive medication).
- Severe hepatic or renal dysfunction.
- Comorbid malignant tumors or other severe chronic diseases.
- Received glucose-lowering therapy within 3 months prior to enrollment OR a total of more than 3 months of glucose-lowering therapy in the past 2 years.
- Diagnosis of rheumatic immune diseases.
- Diagnosis of Raynaud's disease, or intolerance/allergy to cold stimulation.
- Currently pregnant, lactating, or menstruating.
- Contraindications to the injection of the radionuclide tracer Fluorodeoxyglucose (18F-FDG) or other conditions unsuitable for PET-CT examination.
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
Peking Union Medical College Hospital
Beijing
Meng Yang, Doctor, 8601060155493, yangmeng_pumch@126.com
About this study
Official title: Research on the Morphology and Functional Assessment of Brown Adipose Tissue With Photoacoustic Imaging
The goal of this study is to develop a novel, non-invasive, real-time photoacoustic imaging (PAI) technology for quantifying brown adipose tissue (BAT) and to investigate the differences in BAT morphology and metabolic function between healthy individuals and patients with metabolic syndrome.
The main questions it aims to answer are:
Read more
- Can PAI technology quantify BAT metabolic function and establish standardized PAI parameters for BAT assessment?
- Can PAI parameters distinguish the BAT characteristics of healthy volunteers from patients with metabolic syndrome?
Both healthy adults and patients diagnosed with metabolic syndrome will be recruited. Participants will undergo PAI scans of BAT region under normal conditions and after cold exposure to assess BAT activation.
The ultimate goal is to validate this radiation-free PAI method as a convenient and effective tool for evaluating BAT metabolism, potentially aiding in early diagnosis and treatment monitoring of metabolic syndrome.
Read the detailed description
Brown adipose tissue (BAT) is a thermogenic organ that plays a beneficial role in whole-body metabolism by burning calories to generate heat. Its activity is inversely associated with obesity, insulin resistance, and metabolic syndrome. A key challenge in advancing BAT research and its clinical translation is the lack of a non-radiative, non-invasive imaging technique suitable for repeated use in both healthy and diseased populations. The current gold standard, [¹⁸F]FDG-PET/CT, involves ionizing radiation, limiting its application in longitudinal studies and healthy volunteer screening.
Photoacoustic imaging (PAI) is an emerging hybrid modality that combines high optical contrast with deep ultrasound penetration. It can uniquely quantify tissue composition by detecting intrinsic contrasts like lipids and hemoglobin, making it ideally suited for assessing BAT's lipid content, blood perfusion and vascular oxygenation, which are key aspects of its metabolic function.
The objectives of this study are:
- To develop and technically optimize a non-invasive, real-time PAI protocol for quantitative characterization of human BAT morphology and metabolic function.
- To establish a set of standardized, quantitative PAI parameters (e.g., related to blood perfusion, lipid composition, blood oxygen saturation) for BAT assessment.
- To compare the baseline PAI parameters of BAT between healthy volunteers and patients with metabolic syndrome.
Both healthy control group and the patient group will be recruited to undergo PAI scans targeting the supraclavicular BAT depots. All scans will be performed under normal conditions and a standardized cold exposure protocol to stimulate BAT activity. Quantitative PAI parameters (e.g., total hemoglobin, lipid concentration, oxygen saturation) will be extracted and compared between the Healthy Control group and the Patient group using appropriate statistical tests.
This study will not only develop a novel PAI technology for BAT imaging but also utilize it to directly investigate a critical biological question: how BAT differs between health and disease. By establishing PAI-based biomarkers that can distinguish these states, this research aims to provide a powerful, radiation-free tool for the early detection of metabolic dysfunction, risk stratification, and objective monitoring of therapeutic efficacy for insulin resistance and related metabolic syndrome.
- Conditions
- Insulin Resistance, Metabolic Syndrome
- Being tested
- Multi-wavelength PA/US imaging scanning and cold exposure
- Keywords
- Metabolic syndrome, Insulin resistance, Brown adipose tissue, Photoacousitc imaging
- Medical subject headings
- Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-wavelength PA/US imaging scanning and cold exposureDevice
Participants will undergo multi-wavelength PAI scans of BAT region under normal conditions and after 30-60 mins cold exposure to assess BAT activation.
Multi-wavelength PA/US imaging scanning and cold exposureDevice
Participants will undergo multi-wavelength PAI scans of BAT region under normal conditions and after 30-60 mins cold exposure to assess BAT activation.
| Study group | Role | What they receive |
|---|---|---|
| Brown adipose tissue assessment of healthy volunteers based on PA/US imaging | Experimental | Establish a non-invasive, real-time PAI method for quantitative characterization of human BAT morphology and metabolic function and evaluate the baseline of BAT PA parameters in healthy population. Receives: Device: Multi-wavelength PA/US imaging scanning and cold exposure |
| Brown adipose tissue assessment of patients with metabolic syndrome based on PA/US imaging | Experimental | Evaluate the BAT PA parameters in patients with metabolic syndrome. Receives: Device: Multi-wavelength PA/US imaging scanning and cold exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in photoacoustic imaging (PAI)-derived total hemoglobin concentration within brown adipose tissue (BAT) after cold exposure.
The concentration of total hemoglobin (a.u.) within the BAT region of interest will be measured using a co-registered photoacoustic and ultrasound (PA/US) imaging system. The change (Δ) will be calculated as the value after a standardized cold exposure divide the value at baseline.
Measured: Baseline and immediately after a standardized 0.5-1 hour cold exposure procedure
Change in photoacoustic imaging (PAI)-derived lipid concentration within brown adipose tissue (BAT) after cold exposure
The lipid concentration (a.u.) within the BAT region of interest will be measured using a co-registered photoacoustic and ultrasound (PA/US) imaging system. The change (Δ) will be calculated as the value after a standardized cold exposure minus the value at baseline.
Measured: Baseline and immediately after a standardized 0.5-1hour cold exposure procedure.
Change in photoacoustic imaging (PAI)-derived oxygen saturation within brown adipose tissue (BAT) after cold exposure
The oxygen saturation (in %) within the BAT region of interest will be measured using a co-registered photoacoustic and ultrasound (PA/US) imaging system. The change (Δ) will be calculated as the value after a standardized cold exposure minus the value at baseline.
Measured: Baseline and immediately after a standardized 0.5-1 hour cold exposure procedure.
Difference between healthy volunteers and patients with metabolic syndrome in the cold-induced change of photoacoustic imaging (PAI)-derived total hemoglobin concentration within brown adipose tissue (BAT).
The change (Δ) in total hemoglobin concentration (a.u.) after cold exposure (as defined in Outcome 1) will be compared between healthy volunteers and patients diagnosed with metabolic syndrome.
Measured: Through study completion, an average of 24 months.
Difference between healthy volunteers and patients with metabolic syndrome in the cold-induced change of photoacoustic imaging (PAI)-derived lipid concentration within brown adipose tissue (BAT)
The change (Δ) in lipid concentration (a.u.) after cold exposure (as defined in Outcome 2) will be compared between healthy volunteers and patients diagnosed with metabolic syndrome.
Measured: Through study completion, an average of 24 months
Difference between healthy volunteers and patients with metabolic syndrome in the cold-induced change of photoacoustic imaging (PAI)-derived oxygen saturation within brown adipose tissue (BAT)
The change (Δ) in oxygen saturation (in %) after cold exposure (as defined in Outcome 3) will be compared between healthy volunteers and patients diagnosed with metabolic syndrome.
Measured: Through study completion, an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start22 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327684
- Sponsor's protocol ID
- PA/US Brown Adipose Tissue
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Morphology and Functional Assessment of Brown Adipose Tissue With Photoacoustic Imaging
- ClinicalTrials.gov ID
- NCT07327684
- Acronym / sponsor ID
- PA/US Brown Adipose Tissue
- Conditions
- Insulin Resistance, Metabolic Syndrome
- Keywords
- Metabolic syndrome, Insulin resistance, Brown adipose tissue, Photoacousitc imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jan 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.
The goal of this study is to develop a novel, non-invasive, real-time photoacoustic imaging (PAI) technology for quantifying brown adipose tissue (BAT) and to investigate the differences in BAT morphology and metabolic function between healthy individuals and patients with metabolic syndrome.
The main questions it aims to answer are:
- Can PAI technology quantify BAT metabolic function and establish standardized PAI parameters for BAT assessment?
- Can PAI parameters distinguish the BAT characteristics of healthy volunteers from patients with metabolic syndrome?
Both healthy adults and patients diagnosed with metabolic syndrome will be recruited. Participants will undergo PAI scans of BAT region under normal conditions and after cold exposure to assess BAT activation.
The ultimate goal is to validate this radiation-free PAI method as a convenient and effective tool for evaluating BAT metabolism, potentially aiding in early diagnosis and treatment monitoring of metabolic syndrome.
Detailed description
Brown adipose tissue (BAT) is a thermogenic organ that plays a beneficial role in whole-body metabolism by burning calories to generate heat. Its activity is inversely associated with obesity, insulin resistance, and metabolic syndrome. A key challenge in advancing BAT research and its clinical translation is the lack of a non-radiative, non-invasive imaging technique suitable for repeated use in both healthy and diseased populations. The current gold standard, [¹⁸F]FDG-PET/CT, involves ionizing radiation, limiting its application in longitudinal studies and healthy volunteer screening.
Photoacoustic imaging (PAI) is an emerging hybrid modality that combines high optical contrast with deep ultrasound penetration. It can uniquely quantify tissue composition by detecting intrinsic contrasts like lipids and hemoglobin, making it ideally suited for assessing BAT's lipid content, blood perfusion and vascular oxygenation, which are key aspects of its metabolic function.
The objectives of this study are:
- To develop and technically optimize a non-invasive, real-time PAI protocol for quantitative characterization of human BAT morphology and metabolic function.
- To establish a set of standardized, quantitative PAI parameters (e.g., related to blood perfusion, lipid composition, blood oxygen saturation) for BAT assessment.
- To compare the baseline PAI parameters of BAT between healthy volunteers and patients with metabolic syndrome.
Both healthy control group and the patient group will be recruited to undergo PAI scans targeting the supraclavicular BAT depots. All scans will be performed under normal conditions and a standardized cold exposure protocol to stimulate BAT activity. Quantitative PAI parameters (e.g., total hemoglobin, lipid concentration, oxygen saturation) will be extracted and compared between the Healthy Control group and the Patient group using appropriate statistical tests.
This study will not only develop a novel PAI technology for BAT imaging but also utilize it to directly investigate a critical biological question: how BAT differs between health and disease. By establishing PAI-based biomarkers that can distinguish these states, this research aims to provide a powerful, radiation-free tool for the early detection of metabolic dysfunction, risk stratification, and objective monitoring of therapeutic efficacy for insulin resistance and related metabolic syndrome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brown adipose tissue assessment of healthy volunteers based on PA/US imaging | Experimental | Device: Multi-wavelength PA/US imaging scanning and cold exposureEstablish a non-invasive, real-time PAI method for quantitative characterization of human BAT morphology and metabolic function and evaluate the baseline of BAT PA parameters in healthy population. |
| Brown adipose tissue assessment of patients with metabolic syndrome based on PA/US imaging | Experimental | Device: Multi-wavelength PA/US imaging scanning and cold exposureEvaluate the BAT PA parameters in patients with metabolic syndrome. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Multi-wavelength PA/US imaging scanning and cold exposureParticipants will undergo multi-wavelength PAI scans of BAT region under normal conditions and after 30-60 mins cold exposure to assess BAT activation. | Device | Brown adipose tissue assessment of healthy volunteers based on PA/US imaging |
| Multi-wavelength PA/US imaging scanning and cold exposureParticipants will undergo multi-wavelength PAI scans of BAT region under normal conditions and after 30-60 mins cold exposure to assess BAT activation. | Device | Brown adipose tissue assessment of patients with metabolic syndrome based on PA/US imaging |
Primary outcome
Change in photoacoustic imaging (PAI)-derived total hemoglobin concentration within brown adipose tissue (BAT) after cold exposure.
Time frame: Baseline and immediately after a standardized 0.5-1 hour cold exposure procedure
The concentration of total hemoglobin (a.u.) within the BAT region of interest will be measured using a co-registered photoacoustic and ultrasound (PA/US) imaging system. The change (Δ) will be calculated as the value after a standardized cold exposure divide the value at baseline.
Change in photoacoustic imaging (PAI)-derived lipid concentration within brown adipose tissue (BAT) after cold exposure
Time frame: Baseline and immediately after a standardized 0.5-1hour cold exposure procedure.
The lipid concentration (a.u.) within the BAT region of interest will be measured using a co-registered photoacoustic and ultrasound (PA/US) imaging system. The change (Δ) will be calculated as the value after a standardized cold exposure minus the value at baseline.
Change in photoacoustic imaging (PAI)-derived oxygen saturation within brown adipose tissue (BAT) after cold exposure
Time frame: Baseline and immediately after a standardized 0.5-1 hour cold exposure procedure.
The oxygen saturation (in %) within the BAT region of interest will be measured using a co-registered photoacoustic and ultrasound (PA/US) imaging system. The change (Δ) will be calculated as the value after a standardized cold exposure minus the value at baseline.
Difference between healthy volunteers and patients with metabolic syndrome in the cold-induced change of photoacoustic imaging (PAI)-derived total hemoglobin concentration within brown adipose tissue (BAT).
Time frame: Through study completion, an average of 24 months.
The change (Δ) in total hemoglobin concentration (a.u.) after cold exposure (as defined in Outcome 1) will be compared between healthy volunteers and patients diagnosed with metabolic syndrome.
Difference between healthy volunteers and patients with metabolic syndrome in the cold-induced change of photoacoustic imaging (PAI)-derived lipid concentration within brown adipose tissue (BAT)
Time frame: Through study completion, an average of 24 months
The change (Δ) in lipid concentration (a.u.) after cold exposure (as defined in Outcome 2) will be compared between healthy volunteers and patients diagnosed with metabolic syndrome.
Difference between healthy volunteers and patients with metabolic syndrome in the cold-induced change of photoacoustic imaging (PAI)-derived oxygen saturation within brown adipose tissue (BAT)
Time frame: Through study completion, an average of 24 months
The change (Δ) in oxygen saturation (in %) after cold exposure (as defined in Outcome 3) will be compared between healthy volunteers and patients diagnosed with metabolic syndrome.
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 8 Jan 2026.
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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?
A study testing Multi-wavelength PA/US imaging scanning and cold exposure in people with Insulin Resistance and Metabolic Syndrome, run by Peking Union Medical College Hospital 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?
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 8 Jan 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 Meng Yang, Doctor (+8601060155493, yangmeng_pumch@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in photoacoustic imaging (PAI)-derived total hemoglobin concentration within brown adipose tissue (BAT) after cold exposure. (time frame: Baseline and immediately after a standardized 0.5-1 hour cold exposure procedure). 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 8 Jan 2026.