Photoacoustic and ultrasound imaging of brown fat activity

Research on the Morphology and Functional Assessment of Brown Adipose Tissue With Photoacoustic Imaging

This project will test a radiation-free photoacoustic and ultrasound scan to see if it can measure brown fat activity in healthy adults and people with metabolic syndrome.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing)
• Trial ID: NCT07327684 on ClinicalTrials.gov

What this trial studies

This interventional protocol uses multi-wavelength photoacoustic imaging combined with ultrasound to capture brown adipose tissue (BAT) morphology and functional signals such as blood perfusion, lipid content, and oxygenation. Participants include healthy adults and people diagnosed with metabolic syndrome who will undergo scans at baseline and after controlled cold exposure to provoke BAT activation. The study aims to develop standardized, quantitative PAI parameters for BAT and compare those parameters between the two groups. Data will be collected noninvasively and compared with existing expectations from PET/CT-based BAT research to establish technical feasibility and reproducibility.

Who should consider this trial

Good fit: Adults over 18 with metabolic syndrome (and healthy volunteer controls) who can tolerate cold exposure and have no contraindications such as pregnancy, Raynaud's, significant cardiovascular disease, or recent use of sympathomimetic or sympatholytic drugs are ideal candidates.

Not a fit: People who are pregnant or lactating, have Raynaud's or intolerance to cold, have BMI ≥ 30, active cardiovascular or cerebrovascular disease, recent major weight change, or cannot attend on-site imaging visits are unlikely to qualify or benefit from this protocol.

Why it matters

Potential benefit: If successful, this could provide a safe, repeatable, radiation-free imaging method to monitor brown fat function and help with early diagnosis or tracking of metabolic syndrome.

How similar studies have performed: Photoacoustic imaging of BAT is an emerging technique with promising early research showing it can detect perfusion and lipid signals, but it has not yet been validated as a clinical replacement for PET/CT.

Eligibility criteria

Criteria for Healthy Subjects:

(INCLUSION CRITERIA)

1. Healthy individuals over 18 years of age.
2. Body Mass Index (BMI) \< 30.
3. No history of metabolic diseases, rheumatic immune diseases, or cardiovascular and cerebrovascular diseases.
4. Not currently using any sympathomimetic or sympatholytic drugs.
5. Non-smoker and does not consume excessive alcohol.

(EXCLUSION CRITERIA)

1. Weight change \> 5% within 3 months prior to enrollment.
2. BMI ≥ 30.
3. Diagnosis of metabolic disease, rheumatic immune disease, cardiovascular and cerebrovascular disease, or malignant tumor.
4. Use of sympathomimetic or sympatholytic drugs within 3 months prior to enrollment.
5. Smoker or consumes excessive alcohol.
6. Diagnosis of Raynaud's disease, or intolerance/allergy to cold stimulation.
7. Currently pregnant, lactating, or menstruating.
8. 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)

1. Age between 18 and 60 years.
2. Must meet 3 or more of the following criteria:

   1. Waist circumference ≥ 90 cm for males, ≥ 85 cm for females.
   2. 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.
   3. Blood pressure ≥ 130/85 mmHg OR previously diagnosed hypertension and under treatment.
   4. Fasting triglycerides (TG) ≥ 1.7 mmol/L (150 mg/dl).
   5. Fasting high-density lipoprotein cholesterol (HDL-C) \< 1.0 mmol/L (40 mg/dl).
3. 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)

1. Diagnosis of Type 1 diabetes or other specific types of diabetes.
2. Presence of acute diabetic complications or severe chronic diabetic complications.
3. History of acute or chronic pancreatitis, or pancreatic tumors.
4. 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).
5. Severe hepatic or renal dysfunction.
6. Comorbid malignant tumors or other severe chronic diseases.
7. 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.
8. Diagnosis of rheumatic immune diseases.
9. Diagnosis of Raynaud's disease, or intolerance/allergy to cold stimulation.
10. Currently pregnant, lactating, or menstruating.
11. Contraindications to the injection of the radionuclide tracer Fluorodeoxyglucose (18F-FDG) or other conditions unsuitable for PET-CT examination.

Where this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Meng Yang, Doctor

Conditions Insulin Resistance; Metabolic Syndrome; Metabolic syndrome; Insulin resistance; Brown adipose tissue; Photoacousitc imaging