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A Clinical Study on Exercise Guided by CPET to Reduce the Risk of Metabolic Cardiovascular Diseases(C-MET Trial)

Primary Prevention Study of Cardiovascular Diseases and Diabetes in the Population With Metabolic Syndrome-A Clinical Study on Physical Exercise Guided by Cardiopulmonary Exercise Testing to Reduce the Risk of Metabolic Cardiovascular Diseases

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06528639
Enrollment
220
Registered
2024-07-30
Start date
2024-05-21
Completion date
2025-12-31
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome, insufficient exercise

Brief summary

The main purpose of this study is to validate the effect of an individualized exercise prescription developed based on cardiopulmonary exercise testing (CPET) in subjects with metabolic syndrome. This study aims to assess the improvement in cardiovascular metabolic risk associated with the personalized exercise regimen,known as individualized HIIT.

Interventions

BEHAVIORALHIIT

Three times a week, 10 sets each session, for 24 weeks of high-intensity interval training.

Sponsors

Beijing Chao Yang Hospital
CollaboratorOTHER
Guangdong Provincial People's Hospital
CollaboratorOTHER
Peking University Shenzhen Hospital
CollaboratorOTHER
The First Affiliated Hospital of Shanxi Medical University
CollaboratorOTHER
Qingdao Municipal Hospital
CollaboratorOTHER
Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Age between 30 and 65, for both males and females; 2. Inadequate exercise: Sedentary lifestyle: Sitting for more than 6 hours daily over the past 6 months; Insufficient physical activity evaluated by the International Physical Activity Questionnaire (IPAQ), with an average weekly duration of moderate-intensity physical activity less than 150 minutes or high-intensity physical activity less than 75 minutes; 3. Meeting the criteria for metabolic syndrome according to the 2009 AHA/IDF definition: Must have three or more of the following: Abdominal obesity(Waist circumference ≥90 cm for males, ≥80 cm for females); Elevated fasting blood glucose: ≥5.6 mmol/L; Elevated blood pressure: Systolic blood pressure ≥130 mm Hg, or diastolic blood pressure ≥85 mm Hg; Elevated fasting triglycerides (TG): ≥1.7 mmol/L (150 mg/dl); Reduced fasting high-density lipoprotein cholesterol (HDL-C): \<1.0 mmol/L for males, \<1.3 mmol/L for females. Additionally, must meet the following conditions: TG \<500 mg/dl (5.6 mmol/L); fasting blood glucose \<7 mmol/L; baseline blood pressure \<140/90 mm Hg; 4. Willingness to improve health status through reasonable exercise.

Exclusion criteria

1. Contraindications to CPET (Cardiopulmonary Exercise Testing); 2. Positive results in CPET exercise electrocardiogram; 3. The patient has elevated LDL-C levels and has been indicated for statin therapy. 4. Currently undergoing treatment with antihypertensive, antidiabetic, lipid-lowering, or antiarrhythmic medications; 5. The doctor evaluates dietary supplements or over-the-counter medications that may affect the results (such as fish oil products, red yeast rice extract, over-the-counter weight loss drugs, meal replacements, probiotics, berberine, etc.) 6. Mental disorders; 7. Conditions related to exercise impairment, or occurrence of lower limb exercise-related injuries in the past 6 months; 8. Women who are pregnant, breastfeeding, or planning to become pregnant in the near future; 9. Other situations deemed unsuitable for participation in this study by the researchers; 10. Refusal to sign the informed consent form.

Design outcomes

Primary

MeasureTime frameDescription
Change in composite cardiovascular disease risk score (z-score)through study completion, an average of 2 yearThe primary outcome is the change from baseline in the composite cardiovascular disease risk score (z-score) calculated using resting blood pressure, high-density lipoprotein cholesterol, fasting glucose, waist circumference and triglyceride. Each risk factor will be individually standardized and expressed as sex-specific z-score by using the formula = (value - mean)/standard deviation for each participant.

Secondary

MeasureTime frameDescription
Biochemical and metabolic indicatorsthrough study completion, an average of 2 yearBiochemical indicators including GLU(mmol/L),CHO(mmol/L),TG(mmol/L),LDL-C(mmol/L),HDL-C(mmol/L) etc.
CPET (Cardiopulmonary Exercise Testing) related indicatorsthrough study completion, an average of 2 yearPeak oxygen uptake(ml/min)
calf circumference, waist circumference, and hip circumferencethrough study completion, an average of 2 yearIndicators in terms of length include: calf circumference, waist circumference, and hip circumference
Oral Glucose Tolerance Test (OGTT) Related Indicatorsthrough study completion, an average of 2 yearFasting Blood Glucose and Insulin, 30-minute Postprandial Blood Glucose and Insulin, 120-minute Postprandial Blood Glucose and Insulin.

Countries

China

Contacts

Primary ContactJun Gao, PhD
puthxnk@126.com+86-10-82266697

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026