Clinical trial NCT06528639: A Clinical Study on Exercise Guided by CPET to Reduce the Risk of Metabolic Cardiovascular Diseases（C-MET Trial）
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
insufficient exercise
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Chao Yang Hospital
name: Guangdong Provincial People's Hospital
name: Peking University Shenzhen Hospital
name: The First Affiliated Hospital of Shanxi Medical University
name: Qingdao Municipal Hospital
First posted: 2024-07-30
Enrollment: 220
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in composite cardiovascular disease risk score (z-score)
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Biochemical and metabolic indicators
timeFrame: through study completion, an average of 2 year
measure: CPET (Cardiopulmonary Exercise Testing) related indicators
timeFrame: through study completion, an average of 2 year
measure: calf circumference, waist circumference, and hip circumference
timeFrame: through study completion, an average of 2 year
measure: Oral Glucose Tolerance Test (OGTT) Related Indicators
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yi-Da Tang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: