Trial · NCT07908719
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Secondary | Smoking history | Baseline | Smoking history was assessed using a structured questionnaire that recorded current smoking status or former smoking, age at smoking initiation, and pack-years, calculated as cigarettes per day ÷ 20 × years of smoking. |
| Secondary | Alcohol history | baseline | A structured alcohol history questionnaire was used to assess long-term drinking status, alcohol cessation, age at first drink, amount consumed per drinking occasion, and drinking patterns. |
| Secondary | Dietary habits | baseline | Dietary habits were assessed using the China Kadoorie Biobank (CKB) food frequency questionnaire (FFQ), which covers staple foods, vegetables, meat products, dairy products, preserved foods, and nuts, among other food groups. |
| Secondary | Physical activity | baseline | Physical activity was assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) , which asks about walking, moderate-intensity, and vigorous-intensity activity during the last 7 days. Total physical activity was expressed as MET-minutes per week and further categorized into low, moderate, or high levels according to the IPAQ scoring protocol. |
| Secondary | Life quality | baseline | Health-related quality of life was assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) . The instrument comprises a 5-dimension descriptive system (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on 5 levels (1 = no problems to 5 = extreme problems/unable to perform), and a visual analogue scale (EQ-VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health) . |
| Secondary | Anxiety | baseline | Anxiety was assessed using the Generalized Anxiety Disorder-7 (GAD-7) , a 7-item self-report scale. Each item is rated on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day), yielding a total score ranging from 0 to 21, with higher scores indicating greater anxiety severity. Scores of 5, 10, and 15 were used as cut-offs for mild, moderate, and severe anxiety, respectively. |
| Secondary | Cognition | baseline | Cognition was assessed using the Subjective Cognitive Decline Questionnaire-9 (SCD-Q9) , a 9-item self-report scale covering overall memory and temporal comparison (4 items) and daily activity ability (5 items) . Each item is scored 0 (no/never), 0.5 (occasionally), or 1 (yes/often), yielding a total score ranging from 0 to 9, with higher scores indicating more severe subjective cognitive decline. A score of ≥5 was used to define the presence of SCD. |
| Secondary | Sleep quality | baseline | Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) , a 19-item self-report questionnaire covering the past month. The 19 items are grouped into seven components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction), each scored 0 (no difficulty) to 3 (severe difficulty) . The seven component scores are summed to yield a global score ranging from 0 to 21, with higher scores indicating worse sleep quality. A global score of \>7 was used to define poor sleep quality. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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