Profile and Regulatory Network of Exercise in Improving Metabolic Phenotypes of Patients With Prediabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: exercise intervention.
- Who it may be relevant to
- Registry conditions: Prediabetes. Basic parameters: 19 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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).
Primary outcome measures
- 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 outcome measures (2)
- 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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan Hospital, Fudan University — Shanghai
Identifiers
NCT: NCT06633575 · B2024-293R