Photoacoustic/Ultrasound Imaging of Brown Adipose Tissue Activity

NCT07327684 | Recruiting

• 1 other identifier: PA/US Brown Adipose Tissue
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. The main questions it aims to answer are:

1. 1.Can PAI technology quantify BAT metabolic function and establish standardized PAI parameters for BAT assessment?
2. 2.Can PAI parameters distinguish the BAT characteristics of healthy volunteers from patients with metabolic syndrome?

Conditions

Insulin Resistance; Metabolic Syndrome

Keywords

Metabolic syndrome; Insulin resistance; Brown adipose tissue; Photoacousitc imaging

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Through study completion, an average of 24 months

Study Arms (2)

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.

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.

Device: Multi-wavelength PA/US imaging scanning and cold exposure

Interventions

Multi-wavelength PA/US imaging scanning and cold exposure DEVICE

Participants will undergo multi-wavelength PAI scans of BAT region under normal conditions and after 30-60 mins cold exposure to assess BAT activation.

Brown adipose tissue assessment of healthy volunteers based on PA/US imaging

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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).

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Insulin Resistance; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Meng Yang, Doctor

CONTACT

+8601060155493; yangmeng_pumch@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: January 8, 2026
• Study Start: May 22, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-11

Locations

CN (1)