Status:
RECRUITING
A Clinical Study on Exercise Guided by CPET to Reduce the Risk of Metabolic Cardiovascular Diseases（C-MET Trial）
Lead Sponsor:
Peking University Third Hospital
Collaborating Sponsors:
Beijing Chao Yang Hospital
Guangdong Provincial People's Hospital
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
30-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Age between 30 and 65, for both males and females;
- 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;
- 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;
- Willingness to improve health status through reasonable exercise.
Exclusion
- Contraindications to CPET (Cardiopulmonary Exercise Testing);
- Positive results in CPET exercise electrocardiogram;
- The patient has elevated LDL-C levels and has been indicated for statin therapy.
- Currently undergoing treatment with antihypertensive, antidiabetic, lipid-lowering, or antiarrhythmic medications;
- 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.)
- Mental disorders;
- Conditions related to exercise impairment, or occurrence of lower limb exercise-related injuries in the past 6 months;
- Women who are pregnant, breastfeeding, or planning to become pregnant in the near future;
- Other situations deemed unsuitable for participation in this study by the researchers;
- Refusal to sign the informed consent form.
Key Trial Info
Start Date :
May 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06528639
Start Date
May 21 2024
End Date
December 31 2025
Last Update
July 30 2024
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191