Multiscale Causal Disease Warning and Assisted Diagnosis: Multi-omics Mechanisms of Lifestyle Intervention in Regulating Blood Glucose
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Post-intervention incremental area under the glucose curve (iAUC) measured by continuous glucose monitoring (CGM)
研究概览
简要总结
The mechanisms by which lifestyle interventions regulate blood glucose remain incompletely understood. Traditional research has predominantly focused on single targets or pathways, making it difficult to comprehensively elucidate the complex biological regulatory networks. This study systematically investigates the effects of lifestyle interventions on blood glucose and explores their molecular mechanisms. Through integrated multi-omics analysis-including genomics, proteomics, metabolomics, and microbiomics-investigators aim to identify key biological pathways and molecular targets through which dietary, exercise, and other lifestyle interventions influence glucose regulation, as well as discover biomarkers that reflect the efficacy of these interventions. Building upon these findings, investigators will establish a multi-omics molecular network model linking lifestyle interventions to glucose regulation and develop an auxiliary decision-making system for personalised diabetes diagnosis and treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-70 years
排除标准
- •Severe chronic diabetic complications or recent acute diabetic complications
- •Type 1 diabetes mellitus
- •Early-onset diabetes
- •Patients currently using insulin therapy
- •Recent severe hypoglycemic episodes
- •Secondary obesity
- •Pregnancy, severe hepatic/renal diseases, thyroid disorders, acute infections, psychiatric disorders, or other conditions that may interfere with study outcomes
研究组 & 干预措施
Lifestyle intervention Arm
干预措施: Lifestyle Management (Other)
结局指标
主要结局
Post-intervention incremental area under the glucose curve (iAUC) measured by continuous glucose monitoring (CGM)
时间窗: 4 weeks
次要结局
- Proteomics profiling(Baseline and 4 weeks)
- Fecal Metagenomics(Baseline and 4 weeks)
- Fecal Metabolomics(Baseline and 4 weeks)
- Lipidomics profiling(Baseline and 4 weeks)
- Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR) Measured by Continuous Glucose Monitoring(Baseline and 4 weeks)
- Composite glucose metabolism profile(Baseline and 4 weeks)
- Composite kidney function profile(Baseline and 4 weeks)
- Composite liver function profile(Baseline and 4 weeks)
- Lipid profile(Baseline and 4 weeks)
- Inflammatory markers(Baseline and 4 weeks)
- Retinopathy status (digital retinal fundus imaging)(Baseline and 4 weeks)
- Number of sets and repetitions(Each exercise session, aggregated daily up to 28 days)
- Composite dietary intake profile(At each meal, aggregated dayly, up to 28 days)
- Composite physiological monitoring profile from wearables(Daily measurements, up to 28 days)
- Lifestyle management-related parameters(Baseline and 4 weeks)
- Complete Blood Count(Baseline and 4 weeks)
- Routine urine test(Baseline and 4 weeks)
- Mean Glucose measured by continuous glucose monitoring(Baseline and 4 weeks)
- Glucose Variability measured by continuous glucose monitoring(Baseline and 4 weeks)
- Area Under the Curve (AUC) measured by continuous glucose monitoring(Baseline and 4 weeks)
- Body weight(Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks)
- Height(Baseline)
- BMI(Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks)
- Waist, hip and thigh circumference(Baseline, 4 weeks)
- Systolic and Diastolic Blood Pressure(Baseline, 4 weeks)
- Resting heart rate(Baseline, 4 weeks)
- Genomic profiling(Baseline and 4 weeks)
- Metabolomics profiling(Baseline and 4 weeks)
- PBMC Multi-omics Profiling(Baseline and 4 weeks)
- Glycemic Excursions Composite Score from Continuous Glucose Monitoring(Baseline and 4 weeks)
- Exercise heart rate(Each exercise session, aggregated daily up to 28 days)
- Exercise frequency(Each exercise session, aggregated daily up to 28 days)
- Energy expenditure per session(Each exercise session, aggregated daily up to 28 days)
- Exercise duration(Each exercise session, aggregated daily up to 28 days)
- Exercise intensity/load(Each exercise session, aggregated daily up to 28 days)
- Excess post-exercise oxygen consumption(Each exercise session, aggregated daily up to 28 days)
- Fat mass(Baseline, 1 week, 2 week, 3 week, 4 week)
- Fat-free mass(Baseline, 1 week, 2 week, 3 week, 4 week)
- Body fat percentage(Baseline, 1 week, 2 week, 3 week, 4 week)
- Visceral fat area(Baseline, 1 week, 2 week, 3 week, 4 week)
- Muscle mass(Baseline, 1 week, 2 week, 3 week, 4 week)
研究者
Li Huating
Professor
Shanghai 6th People's Hospital