Multi-wavelength PA/US imaging scanning and cold exposureMulti-wavelength PA/US imaging scanning and cold exposure
Multi-wavelength PA/US imaging scanning and cold exposure: 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 exposure: 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 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. Can PAI technology quantify BAT metabolic function and establish standardized PAI parameters for BAT assessment?
2. 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Change in photoacoustic imaging (PAI)-derived total hemoglobin concentration within brown adipose tissue (BAT) after cold exposure. — 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 — 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 — 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). — 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) — 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) — 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.
Trial sites (1)
Facility
City
Region
Status
Peking Union Medical College Hospital
Beijing
China
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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