Exercise effects on metabolism and blood-cell networks in people with prediabetes

Profile and Regulatory Network of Exercise in Improving Metabolic Phenotypes of Patients With Prediabetes

This 8-week exercise program will try to improve weight, lab measures, and blood-cell and metabolic biomarkers in overweight or obese adults with prediabetes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 19 Years to 55 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06633575 on ClinicalTrials.gov

What this trial studies

This single-center, single-arm self-controlled study will enroll 40 overweight or obese Han Chinese adults with prediabetes for an 8-week supervised exercise program. Clinical measures including body weight, body fat, laboratory blood tests, and resting energy expenditure will be recorded before and after the intervention. Peripheral blood mononuclear cells will be profiled by single-cell sequencing and integrated with metabolomics and phenomic data to identify regulatory networks and potential biomarkers of exercise response. Participants with recent weight-loss interventions, medications affecting metabolism, major organ disease, uncontrolled hypertension, endocrine disorders, or musculoskeletal limitations will be excluded.

Who should consider this trial

Good fit: Ideal participants are Han Chinese adults who are overweight or obese with prediabetes-range fasting glucose, 2-hour glucose, or HbA1c, are not on anti-hyperglycemic or weight-loss medications, and can consent to and complete an 8-week exercise program.

Not a fit: People with uncontrolled hypertension, serious heart/liver/kidney disease, endocrine disorders that affect glucose, recent major weight change, recent use of medications like metformin or GLP-1 agonists, or musculoskeletal problems preventing exercise are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this work could identify biomarkers and mechanisms that explain how exercise improves metabolism and help tailor lifestyle recommendations for people with prediabetes.

How similar studies have performed: Regular exercise is well-known to improve weight and glycemic measures in prediabetes, but using single-cell and multi-omics profiling to find specific exercise-response biomarkers is relatively novel and not yet proven at scale.

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

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ying Chen

Conditions Prediabetes