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Completed

NCT Number: NCT07825467

Brown Adipose Tissue Activity and NAFLD Progression

This single-center, non-interventional observational study investigated the association between brown adipose tissue (BAT) activity and nonalcoholic fatty liver disease (NAFLD)-related clinical characteristics. Participants who had previously undergone clinically indicated 18F-FDG PET/CT examinations were enrolled. Existing PET/CT imaging data were collected and used to assess BAT activity.

Peripheral blood samples were collected for plasma analysis. The study aimed to identify circulating factors associated with BAT activity and to evaluate their relationships with NAFLD-related clinical and metabolic characteristics. No additional PET/CT examination, investigational treatment, or other therapeutic intervention was performed as part of this study.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

About this study

This was a single-center, non-interventional observational study designed to investigate the relationship between brown adipose tissue (BAT) activity and NAFLD-related clinical and metabolic characteristics.

Participants who had already undergone 18F-FDG PET/CT examinations for clinical purposes were recruited. No additional PET/CT examination was performed for this study. Existing PET/CT imaging data were collected and analyzed to assess BAT activity. The maximum standardized uptake value (SUVmax) was used as an imaging parameter to evaluate BAT activity.

Peripheral blood samples were collected from participants for plasma analysis. Plasma samples were used to investigate circulating factors associated with BAT activity and their relationships with NAFLD-related clinical and metabolic parameters.

This study did not assign any investigational drug, device, behavioral intervention, or additional imaging examination. Only previously acquired PET/CT imaging data, peripheral blood samples, and relevant clinical information were collected and analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who had undergone clinically indicated 18F-FDG PET/CT examination.
  • Willing and able to provide written informed consent and comply with the study procedures.
  • No long-term use of medications such as glucocorticoids or lipid-lowering drugs; no smoking or excessive alcohol consumption (alcohol intake <20 g/day).
  • High BAT activity group: BAT SUVmax ≥2.0, with clear BAT activation in the cervical, shoulder, or supraclavicular regions on PET/CT.
  • Intermediate BAT activity group: 1.0 ≤ BAT SUVmax <2.0.
  • Low BAT activity group: BAT SUVmax <1.0 or no detectable BAT distribution on PET/CT.

Exclusion criteria

  • Use of medications affecting metabolism within the previous 3 months, such as beta-blockers or thyroid hormones.
  • Contraindications to PET/CT examination, such as claustrophobia or contrast-agent allergy.
  • Pregnancy or breastfeeding.

Treatment and study plan

Primary outcomes

  1. Number of Differentially Abundant Plasma Proteins Across BAT Activity Group

    Time frame: At enrollment (single blood collection and assessment of previously acquired PET/CT data)

    Participants will be categorized into high, intermediate, and low brown adipose tissue (BAT) activity groups according to BAT SUVmax obtained from previously acquired clinical 18F-FDG PET/CT imaging data. Plasma protein abundance will be measured using label-free quantitative proteomics and expressed as normalized protein abundance. The outcome measure will be the number of plasma proteins meeting the prespecified statistical criteria for differential abundance among the three BAT activity groups.

Secondary outcomes

  1. Number of Differentially Abundant Plasma Proteins Across BAT Activity Groups

    Time frame: At enrollment

    Participants will be categorized into high, intermediate, and low brown adipose tissue (BAT) activity groups according to BAT SUVmax obtained from previously acquired clinical 18F-FDG PET/CT imaging data. Plasma protein abundance will be measured using label-free quantitative proteomics and expressed as normalized protein abundance. The outcome measure will be the number of plasma proteins meeting the prespecified statistical criteria for differential abundance among the three BAT activity groups.

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Registry information

Official study title

A Single-Center, Non-Interventional Clinical Study Investigating the Association Between Brown Adipose Tissue Activity and NAFLD Progression

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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