The Cross-sectional and Longitudinal Study of Relationship Between Non-alcoholic Fatty Liver Disease and Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Cognitive Assessment (MMSE)
研究概览
简要总结
The purpose of this study is to explore the relationship between Non-alcoholic fatty liver disease and cognitive impairment and evaluate the effect of metabolic surgery or lifestyle intervention on cognition.
详细描述
Previous research has shown that Non-alcoholic fatty liver disease (NAFLD) is associated with an increased risk of cognitive impairment. Even though there are many noninvasive tests available, a liver biopsy is still required for the accurate diagnosis of NAFLD. However, there are now few studies on cognitive function in patients with NAFLD based on pathological diagnosis. On one hand, in the cross-sectional study, biometric measurements, cognitive assessment, magnetic resonance imaging (MRI) results are analysed to explore the differences among control subjects and NAFLD patients undergoing liver biopsy. One the other hand, in the longitudinal study, changes in cognitive scales and MRI results in NAFLD patients both at baseline and 12-48 months after intervention are collected to investigate whether surgical intervention and weight control benefit brain function.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>6 years of education
- •right handed
排除标准
- •consumed excessive alcohol (≥140 g/week for males or ≥ 70 g/week for females)
- •with history of other liver diseases including chronic hepatitis, biliary obstructive diseases or autoimmune hepatitis
- •with thyroid diseases
- •in a state of anxiety or depression
- •inability to complete cognitive function scales
结局指标
主要结局
Cognitive Assessment (MMSE)
时间窗: 1 day
Mini-Mental State Examination (MMSE) scores from 0-30, and the test means better cognition with a higher score.
Physical assessments.
时间窗: 1 day
BMI (body mass index) in kg/m\^2
Participants' personal information
时间窗: 1 day
Self-reported information (age in years, gender, education in years)
Cognitive Assessment (MoCA)
时间窗: 1 day
he Montreal Cognitive Assessment (MoCA) scores from 0-30, and the test means better cognition with a higher score.
Cognitive Assessment (RBANS)
时间窗: 1 day
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores from 0-800, and the test means better cognition with a higher score.
brain activation in fMRI
时间窗: 1 day
All patients underwent odor-induced task fMRI on a 3.0T MR scanner with 222 volumes for task fMRI and 230 volumes for resting-state and functional fMRI. The odor-induced task consisted of "fresh air" "rest" and "scent". Odor-induced brain activation was assessed by a general linear model using Statistical Parametric Mapping 12 (SPM12) software. Following extraction of the three separate conditions "fresh air," "scent," and "rest" from the whole sequence, contrasts were made for each participant between "fresh air \> rest" and "scent \> rest." Odor-induced fMRI data were analyzed in the mask of the olfactory network, including the regions of bilateral parahippocampus, amygdala, piriform cortex, insula, orbitofrontal cortex, hippocampus, and entorhinal cortices.
次要结局
- Change of Cognitive Assessment (MMSE) from baseline(12-48 months)
- Change of brain MRI measurement from baseline(12-48 months)
- Change of weight from baseline(12-48 months)
- Change of Cognitive Assessment (RBANS) from baseline(12-48 months)
- Change of Cognitive Assessment (MoCA) from baseline(12-48 months)
研究者
Yan Bi
Chief Physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School