Mechanism Study of Metabolic Response and Health Benefit Induced by Exercise

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prediabetes
• Intervention / Treatment: Behavioral: exercise intervention

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying Chen; Phone Number: 86+19542806360; Email: chen.ying4@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise intervention	Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes of serum metabolites detected by metabolomic profiling	From enrollment to the end of exercise intervention at 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Changes of peripheral blood CD45+ cells detected by single cell sequencing	From enrollment to the end of exercise intervention at 8 weeks

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Estimated): October 9, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: FE22223R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No