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

NCT06633575 | Recruiting

• 1 other identifier: B2024-293R
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes of peripheral blood CD45+ cells detected by single cell sequencing

  From enrollment to the end of exercise intervention at 8 weeks

Secondary Outcomes (2)

• Changes of anthropometrics including body weight, body fat, waist-to-hip ratio

  From enrollment to the end of exercise intervention at 8 weeks

• 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

Other Outcomes (4)

• Changes of resting energy expenditure

  From enrollment to the end of exercise intervention at 8 weeks

• Changes of serum metabolites detected by metabolomic profiling

  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

Study Arms (1)

exercise intervention

EXPERIMENTAL

Behavioral: exercise intervention

Interventions

exercise intervention 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).

exercise intervention

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Han Chinese
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Ying Chen

CONTACT

86+19542806360; chen.ying4@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 9, 2024
• Study Start: October 12, 2024
• Primary Completion (Estimated): October 9, 2027
• Study Completion (Estimated): October 9, 2027
• Last Updated: March 12, 2026

Record last verified: 2025-09

Locations

CN (1)