Clinical trial NCT06633575: Profile and Regulatory Network of Exercise in Improving Metabolic Phenotypes of Patients with Prediabetes
Official title: Profile and Regulatory Network of Exercise in Improving Metabolic Phenotypes of Patients with Prediabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prediabetes
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a single-arm, self-control, single-center study to investigate the molecular mechanism under exercise improving metabolism of patients with prediabetes. 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 clinical phenotypes such as body weight, body fat, laboratory values, and resting energy expenditure before and after exercise 2) the changes of peripheral blood mononuclear cell by single cell sequencing 3) search for potential biomarkers of exercise in improving metabolism through multi-omics integrated analysis of single-cell transcriptome, phenomics, metabolomics, etc.


Eligibility criteria: 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

Primary outcomes:
measure: Changes of peripheral blood CD45+ cells detected by single cell sequencing
timeFrame: From enrollment to the end of exercise intervention at 8 weeks
Secondary outcomes:
measure: Changes of anthropometrics including body weight, body fat, waist-to-hip ratio
timeFrame: From enrollment to the end of exercise intervention at 8 weeks
measure: Changes of laboratory values including plasma glucose, insulin, lipids, liver enzymes, thyroid hormones, inflammation cytokines
timeFrame: From enrollment to the end of exercise intervention at 8 weeks
Other outcomes:
measure: Changes of resting energy expenditure
timeFrame: From enrollment to the end of exercise intervention at 8 weeks
measure: Changes of serum metabolites detected by metabolomic profiling
timeFrame: From enrollment to the end of exercise intervention at 8 weeks
measure: Changes of fecal microbial composition detected by metagenomics
timeFrame: From enrollment to the end of exercise intervention at 8 weeks
measure: Changes of serum proteins detected by proteomics
timeFrame: From enrollment to the end of exercise intervention at 8 weeks
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