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

NCT ID: NCT06633575

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-09
• Study Completion Date: 2027-10-09

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.

Conditions

Prediabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

exercise intervention

Group Type: EXPERIMENTAL

exercise intervention

Intervention Type: BEHAVIORAL

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).

Interventions

exercise 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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ying Chen

Role: CONTACT

chen.ying4@zs-hospital.sh.cn

86+19542806360

Other Identifiers

B2024-293R

Identifier Type: -

Identifier Source: org_study_id