Mechanism Study of Metabolic Response and Health Benefit Induced by Exercise
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Changes of serum metabolites detected by metabolomic profiling
研究概览
简要总结
This study is a single-arm, self-control, single-center study to investigate the mechanism under exercise inducing metabolic response and health benefit. 40 overweight/obese patients with prediabetes will be recruited in this study and instructed to participate in an 8-week exercise program. We aim to investigate 1) the changes of phenotypes such as body weight, body fat, laboratory values, appetite, resting energy expenditure, myokine-adipokine before and after exercise 2) the changes of serum metabolomics 3) search for potential biomarkers of exercise through multi-omics integrated analysis of metabolomics, metagenomics, phenomics, single-cell transcriptome, etc.
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
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Han Chinese
- •5.6 mmol/L≤fasting blood glucose<7 mmol/L, and/or 7.8 mmol/L≤2h-postload glucose<11.1mmol/L, and/or 5.7% ≤HbA1c<6.5% without anti-hyperglycemic medicine treatment
- •Voluntary participation and provide informed consent
排除标准
- •Participated in any clinical study in relation to weight-loss in the past 1 year
- •Had a weight change of more than 10% present weight in the past 1 year
- •Had a drug usage not suitable for this study in the past 3 months, such as hormone drug, orlistat, metformin, GLP-1 receptor agonists, lipid-lowering agents, liver protection drug, etc
- •Presence of diseases influencing glucose and lipid metabolism ,such as hyperthyroidism, hypothyroidism, Cushing syndrome, etc
- •Poorly controlled blood pressure: systolic blood pressure≥180mmHg, and/or diastolic blood pressure≥100mmHg
- •Presence of serious heart, liver, kidney or systemic diseases
- •Presence of skeletal and muscular diseases which make it difficult to exercise
- •Received any kind of surgery in the past 1 year
- •COVID-19 positive or recovery from COVID-19 within 4 weeks
- •Presence of eating disorders or have a history of eating disorders
- •Presence of sleep disorders
- •Work in disrupted circadian rhythms
- •Pregnancy and breastfeeding women
结局指标
主要结局
Changes of serum metabolites detected by metabolomic profiling
时间窗: From enrollment to the end of exercise intervention at 8 weeks
次要结局
- Changes of anthropometrics including body weight, body fat, waist-to-hip ratio(From enrollment to the end of exercise intervention at 8 weeks)
- Changes of laboratory values including plasma glucose, insulin, lipids, liver enzymes, thyroid hormones, inflammation cytokines(From enrollment to the end of exercise intervention at 8 weeks)