A Multi-modal Cohort Study of Brown Adipose Tissue Based on Paired Comparisons at Room Temperature and After Cold Exposure

Condition(s) studied

Investigational drug(s) / intervention(s)

cold exposure: Participants will undergo saliva and blood collection and complete PET-CT scans both at room temperature and after cold exposure. The room-temperature PET-CT scan will be performed according to routine clinical protocols without the need for additional oral or injectable medications. For the post-cold-exposure scan, participants will only need to receive 2 hours of moderate cold exposure prior to the scan to adequately activate brown adipose tissue (they will be arranged to rest in a room maintained at 16-19 °C).

Study summary

This study is a single-center, prospective clinical study that plans to prospectively recruit volunteers aged 18-40 years, including metabolically healthy individuals and those with diabetes mellitus and hyperlipidemia. Participants will undergo \[¹⁸F\]fluorodeoxyglucose positron emission tomography/computed tomography (\[¹⁸F\]FDG PET/CT) scans both at room temperature and after cold exposure. The planned sample size is 500 participants. The study will systematically collect baseline data, questionnaire responses, \[¹⁸F\]FDG PET/CT images acquired under both conditions, as well as saliva and blood samples.

The study aims to establish a clinical-imaging-biological multimodal brown adipose tissue (BAT) cohort with paired pre- and post-cold exposure comparisons. Based on this cohort, we expect to achieve new breakthroughs in BAT detection methods, assessment criteria, and the understanding of its genetic mechanisms.

Eligibility

Primary outcome measure(s)

• brown adipose tissue at baseline — Baseline at room-temperature
  The volume of brown adipose tissue at room-temperature. BAT was diagnosed on ¹⁸F-FDG PET-CT according to BARCIST 1.0, defined as areas with SUVbm ≥ 1.5 on PET and CT Hounsfield units between -190 and -10, after excluding obvious non-fat tissues within this range such as lung.
• brown adipose tissue at baseline — Baseline at room-temperature
  The SUVmax of brown adipose tissue at room-temperature. BAT was diagnosed on ¹⁸F-FDG PET-CT according to BARCIST 1.0, defined as areas with SUVbm ≥ 1.5 on PET and CT Hounsfield units between -190 and -10, after excluding obvious non-fat tissues within this range such as lung.
• brown adipose tissue at baseline — Baseline at room-temperature
  The SUVmean of brown adipose tissue at room-temperature. BAT was diagnosed on ¹⁸F-FDG PET-CT according to BARCIST 1.0, defined as areas with SUVbm ≥ 1.5 on PET and CT Hounsfield units between -190 and -10, after excluding obvious non-fat tissues within this range such as lung.
• brown adipose tissue after cold exposure — After 2-hour cold exposure within 2 weeks
  The volume of brown adipose tissue after 2-hour cold exposure. BAT was diagnosed on ¹⁸F-FDG PET-CT according to BARCIST 1.0, defined as areas with SUVbm ≥ 1.5 on PET and CT Hounsfield units between -190 and -10, after excluding obvious non-fat tissues within this range such as lung.
• brown adipose tissue after cold exposure — After 2-hour cold exposure within 2 weeks
  The SUVmax of brown adipose tissue after 2-hour cold exposure. BAT was diagnosed on ¹⁸F-FDG PET-CT according to BARCIST 1.0, defined as areas with SUVbm ≥ 1.5 on PET and CT Hounsfield units between -190 and -10, after excluding obvious non-fat tissues within this range such as lung.
• brown adipose tissue after cold exposure — After 2-hour cold exposure within 2 weeks
  The SUVmean of brown adipose tissue after 2-hour cold exposure. BAT was diagnosed on ¹⁸F-FDG PET-CT according to BARCIST 1.0, defined as areas with SUVbm ≥ 1.5 on PET and CT Hounsfield units between -190 and -10, after excluding obvious non-fat tissues within this range such as lung.

Trial sites (1)

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