Prediabetes
Conditions
Brief summary
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.
Interventions
BEHAVIORALexercise intervention
Patients will participate in an 8-week supervised aerobic exercise program, the intensity was set at the moderate to vigorous intensity (≥150mins/week exercise on the treadmill).
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Han Chinese 2. 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 3. Voluntary participation and provide informed consent
Exclusion criteria
1. Participated in any clinical study in relation to weight-loss in the past 1 year 2. Had a weight change of more than 10% present weight in the past 1 year 3. 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 4. Presence of diseases influencing glucose and lipid metabolism ,such as hyperthyroidism, hypothyroidism, Cushing syndrome, etc 5. Poorly controlled blood pressure: systolic blood pressure≥180mmHg, and/or diastolic blood pressure≥100mmHg 6. Presence of serious heart, liver, kidney or systemic diseases 7. Presence of skeletal and muscular diseases which make it difficult to exercise 8. Received any kind of surgery in the past 1 year 9. COVID-19 positive or recovery from COVID-19 within 4 weeks 10. Presence of eating disorders or have a history of eating disorders 11. Presence of sleep disorders 12. Work in disrupted circadian rhythms 13. Pregnancy and breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of serum metabolites detected by metabolomic profiling | From enrollment to the end of exercise intervention at 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Changes of anthropometrics including body weight, body fat, waist-to-hip ratio | From enrollment to the end of exercise intervention at 8 weeks |
Other
| Measure | Time frame |
|---|---|
| Changes of resting energy expenditure | From enrollment to the end of exercise intervention at 8 weeks |
| Changes of peripheral blood CD45+ cells detected by single cell sequencing | From enrollment to the end of exercise intervention at 8 weeks |
| Changes of fecal microbial composition detected by metagenomics | From enrollment to the end of exercise intervention at 8 weeks |
| Changes of serum proteins detected by proteomics | From enrollment to the end of exercise intervention at 8 weeks |
Contacts
Primary ContactYing Chen
Outcome results
None listed