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NCT Number: NCT06633575

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

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Xiaoying Li

CONTACT

[email protected]

02164041990

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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).

Primary outcomes

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

    Time frame: From enrollment to the end of exercise intervention at 8 weeks

Secondary outcomes

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

    Time frame: From enrollment to the end of exercise intervention at 8 weeks

  2. Changes of laboratory values including plasma glucose, insulin, lipids, liver enzymes, thyroid hormones, inflammation cytokines

    Time frame: From enrollment to the end of exercise intervention at 8 weeks

Other outcomes

  1. Changes of resting energy expenditure

    Time frame: From enrollment to the end of exercise intervention at 8 weeks

  2. Changes of serum metabolites detected by metabolomic profiling

    Time frame: From enrollment to the end of exercise intervention at 8 weeks

  3. Changes of fecal microbial composition detected by metagenomics

    Time frame: From enrollment to the end of exercise intervention at 8 weeks

  4. Changes of serum proteins detected by proteomics

    Time frame: From enrollment to the end of exercise intervention at 8 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Chen

CONTACT

[email protected]

86+19542806360

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 9, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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