RecruitingNot ApplicableNCT06633575

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

Sponsor

Shanghai Zhongshan Hospital

Enrollment

40 participants

Start Date

Oct 12, 2024

Study Type

INTERVENTIONAL

Conditions

Prediabetes

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

Min Age: 19 YearsMax Age: 55 Years

Inclusion Criteria3

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

Exclusion Criteria13

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

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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).