Mechanism Study of Metabolic Response and Health Benefit Induced by Exercise

NCT06633653 | Not Yet Recruiting

• 1 other identifier: FE22223R
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a single-arm, self-control, single-center study to investigate the mechanism under exercise inducing metabolic response and health benefit. 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 phenotypes such as body weight, body fat, laboratory values, appetite, resting energy expenditure, myokine-adipokine before and after exercise 2) the changes of serum metabolomics 3) search for potential biomarkers of exercise through multi-omics integrated analysis of metabolomics, metagenomics, phenomics, single-cell transcriptome, etc.

Conditions

Prediabetes

Outcome Measures

Primary Outcomes (1)

• Changes of serum metabolites detected by metabolomic profiling

  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 fecal microbial composition detected by metagenomics

  From enrollment to the end of exercise intervention at 8 weeks

• Changes of serum proteins detected by proteomics

  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

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 9, 2024
• Primary Completion (Estimated): October 9, 2027
• Study Completion (Estimated): October 9, 2027
• Last Updated: October 9, 2024

Record last verified: 2024-10