Research on Brain Function of Metabolism-based Artificial Intelligence Assisted Clinical Classification of Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Functional magnetic resonance imaging of brain
研究概览
简要总结
The purpose of this study was to investigate the differences and similarities of brain function in patients with four subtypes of obesity, and the relationship between brain function changes and complications after weight loss and metabolic improvement. 120 patients with obesity and 30 healthy individuals with normal BMI were enrolled.
详细描述
Although the investigators have clinically observed significant differences in appetite and metabolic status in patients with the above four types of obesity, the brain functional characteristics of different obesity subtypes and their relationship with metabolic markers are still unclear. Based on this, in this project, the investigators plan to explore further the similarities and differences in brain function in patients with four subtypes of obesity and the relationship between brain function changes after weight loss and metabolic improvement and the occurrence of complications.
120 patients with obesity and 30 healthy individuals with normal BMI were enrolled.
All patients with obesity underwent LSG. A multidisciplinary team evaluated participants with obesity at baseline, 1, 3, 6, and 12 months after laparoscopic sleeve gastrectomy (LSG). Anthropometrics, Metabolic indicators, sex hormones, menstruation，glucose-lipid metabolic markers, and hepatic steatosis assessed by FibroScan(CAP value and E value) were measured baseline and postoperative. Resting and task state functional magnetic resonance imaging (fMRI) measurements were performed at baseline for all participants at two-time points before and after meals. Measurements were repeated in obese patients 6 months after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ranged from 16-65 years old
- •BMI over 37.5kg/m2, or BMI over 32.5kg/m2 with diabetes which meets the recommended cut-off bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China.
排除标准
- •secondary causes of obesity such as hypothalamic obesity, Cushing syndrome, hypophysis dysfunction, etc
- •pregnancy or location
- •contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesion, etc
- •severe heart, liver, and kidney dysfunction
- •organic and systemic diseases intolerant of surgery.
结局指标
主要结局
Functional magnetic resonance imaging of brain
时间窗: 6 months
The subjects underwent fMRI scans before and after eating. Blood oxygen levels depend on functional brain imaging (Blod-fMRI) to collect the brain's local BLOD response (hemodynamic response) caused by the electrical activity of neurons. The stronger the BLOD response, the more excitability of the local brain. A region-of-interest (ROI) approach was applied with the use of masks that were established in an independent study of normal-weight subjects to be markers of satiety or predictors of food choices. ROIs included the left and right ventral striatum (nucleus accumbens), the left and right amygdala, the left and right dorsal striatum (caudate and putamen), the left and right insula, and the medial orbital frontal cortex (mOFC). functional connectivity analysis analyzes the compatibity of temporal signals of two or more pairs of brain regions or the differences in the strength of functional connections under different experimental conditions
次要结局
- FBG(12 months)
- FINS(12 months)
- HDL-C(12 months)
- SHBG(12 months)
- UA(12 months)
- LDL-C(12 months)
- BMI(12 months)
- Waist/hip Ratio(12 months)
- DXA(dual energy x-ray absorptiometry)(12 months)
- Abdominal Fat Measurement(12 months)
- HbA1c (%)(12 months)
- AST(12 months)
- PBG(12 months)
- PINS(12 months)
- ALT(12 months)
- HOMA-IR(12 months)
- TSH(12 months)
- FT3(12 months)
- FT4(12 months)
- DHEAS(12 months)
- 25OHD(12 months)
- Ca(12 months)
- GLP-1(12 months)
- TT(12 months)
- FT(12 months)
- PTH(12 months)
- LCN2(12 months)
- HADS(12 months)
- Ghrelin(12 months)
- Leptin(12 months)
- S100(12 months)
- GFAP(12 months)
- TEFQ-R21(12 months)
研究者
Shen Qu
Clinical Professor and Principal Investigator
Shanghai 10th People's Hospital