A Single-Center, Non-Interventional Clinical Study Investigating the Association Between Brown Adipose Tissue Activity and NAFLD Progression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Number of Differentially Abundant Plasma Proteins Across BAT Activity Group
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Low BAT activity group: BAT SUVmax <1.0 or no detectable BAT distribution on PET/CT.
排除标准
- •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.
研究组 & 干预措施
High BAT Activity Group
Participants with high brown adipose tissue (BAT) activity, defined as BAT SUVmax ≥2.0 based on 18F-FDG PET/CT imaging data.
Intermediate BAT Activity Group
Participants with intermediate brown adipose tissue (BAT) activity, defined as 1.0 ≤ BAT SUVmax <2.0 based on 18F-FDG PET/CT imaging data.
Low BAT Activity Group
Participants with low brown adipose tissue (BAT) activity, defined as BAT SUVmax <1.0 or no detectable BAT activation based on 18F-FDG PET/CT imaging data.
结局指标
主要结局
Number of Differentially Abundant Plasma Proteins Across BAT Activity Group
时间窗: 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.
次要结局
- Number of Differentially Abundant Plasma Proteins Across BAT Activity Groups(At enrollment)
研究者
ChenMingkai
Professor and Chief Physician, Department of Gastroenterology
Renmin Hospital of Wuhan University