Clinical Classification and Imaging Markers in Patients of Obesity
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Brain imaging features in patients with obesity by fMRI
研究概览
简要总结
This is an observational study to explore the etiology and clinical classification in patients with obesity and to achieve personalized treatment.
详细描述
In this project, individuals with obesity and control individuals were recruited and followed up every year. Clinical neuropsychological scores, olfactory function tests, and functional magnetic resonance imaging (fmri) were performed to describe the brain function characteristics under different odor stimulation in fasting and after eating, and to explore the pathogenesis and clinical classification of obese patients. The correlation analysis between imaging analysis values and clinical laboratory data, neuropsychological scores and olfactory behavior scores was performed to explore indicators related to cognitive decline and provide new insights into the etiology and classification of obese patients. Combined with clinical evaluation and imaging examination, the changes of cognitive behavior and brain structure and function in obese patients were followed up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with BMI≥28kg/m2
- •Aged 18-65 years of both sexes, right-handed
- •At least 6 years of education
- •Patients agreed and signed the informed consent
排除标准
- •Fewer than 6 years of education
- •Left-handedness
- •Acute metabolic complications such as diabetic ketoacidosis
- •Hyperglycaemic hyperosmolar state and hypoglycaemic coma within the previous 3 months; history or presence of neurological or psychiatric disorders;
- •Presence of hypothyroidism;
- •History of malignancy, or severe kidney or liver dysfunction.
结局指标
主要结局
Brain imaging features in patients with obesity by fMRI
时间窗: From 2024 to 2028
total brain volume, grey matter volume, white matter volume,cerebrospinal fluid volume, and nuclear bulk volume by MRI-derived normalized measures. 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 fMRI.
Biomarkers of patients with obesity by blood sample
时间窗: From 2024 to 2028
Diagnostic biomarkers, predictive biomarkers, and prognostic biomarker in patients with obesity by blood sample
Clinical classification of patients with obesity
时间窗: From 2024 to 2028
Based on the exploration of the unique brain imaging and biomarkers in patients with obesity, the clinical classification of obese patients was carried out.
Prevention and intervention strategies for obesity based on clinical classification
时间窗: From 2024 to 2028
According to the clinical classification of obesity investigated in our previous study, personalized prevention and treatment strategies are designed to effectively slow down or reverse the obesity disease.
次要结局
未报告次要终点
研究者
Yan Bi
Clinical Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School