Not yet recruitingNCT06633653Updated Oct 9, 2024

Mechanism Study of Metabolic Response and Health Benefit Induced by Exercise

An interventional study of exercise intervention in Prediabetes, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting. Open to participants aged 19 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-10-09.

Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 40
Allocation: Not applicable
Ages: 19 Years to 55 Years
Sex: All

Study 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 studied

Prediabetes

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Prediabetic State 1,021

In context

Prediabetic State

1,021 studies on the registry are indexed under Prediabetic State; 242 are open to participants now.

This study's planned enrollment of 40 is below the median of 66 across 861 interventional studies indexed under Prediabetic State.

Browse Prediabetic State studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 648 studies on the registry; 289 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 40 participants (estimated)

Study arms

Experimental
exercise intervention
Behavioral: exercise intervention

Interventions

Behavioralexercise 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 researchers measure

Primary outcomes

Changes of serum metabolites detected by metabolomic profiling
Time frame: From enrollment to the end of exercise intervention at 8 weeks

Secondary outcomes

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

Other outcomes

Changes of resting energy expenditure
Time frame: From enrollment to the end of exercise intervention at 8 weeks
Changes of fecal microbial composition detected by metagenomics
Time frame: From enrollment to the end of exercise intervention at 8 weeks
Changes of serum proteins detected by proteomics
Time frame: From enrollment to the end of exercise intervention at 8 weeks
Changes of peripheral blood CD45+ cells detected by single cell sequencing
Time frame: From enrollment to the end of exercise intervention at 8 weeks

Study locations

No study locations are listed for this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2024; primary completion for Oct 2027, 36 months later.

Of 415 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 36 months is above that.

Counting every sponsor, half of 466 studies reached it within 24 months; a quarter within 11 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 25, 2024
First posted: Oct 9, 2024
StartEst.: Oct 9, 2024
Primary completionEst.: Oct 9, 2027
CompletionEst.: Oct 9, 2027
Last update: Oct 9, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06633653
Lead sponsor: Shanghai Zhongshan Hospital
Responsible party: Sponsor
First posted: Oct 9, 2024
Start date: Oct 9, 2024 (estimated)
Primary completion: Oct 9, 2027 (estimated)
Completion: Oct 9, 2027 (estimated)
Last update: Oct 9, 2024

Study contacts

Ying Chen

Contact

chen.ying4@zs-hospital.sh.cn

86+19542806360

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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