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

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Behavioral: HIIT

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Gao, PhD; Phone Number: +86-10-82266697; Email: puthxnk@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Wenyao Wang, MD, PhD; Phone Number: 18810488381

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individualized HIIT Group; Participants in this group will receive a type of exercise prescription of High-Intensity Interval Training (HIIT). They will undergo supervised individualized intermittent high-intensity training (HIIT) guided by CPET three times per week under the supervision of the hospital. Participants will also receive guidance on healthy dietary habits. At the end of the 12th week, CPET and inspiratory muscle strength tests will be conducted to evaluate the training effects and adjust the exercise prescription. The total duration of the training will be 24 weeks	Behavioral: HIIT; Three times a week, 10 sets each session, for 24 weeks of high-intensity interval training.
No Intervention: Control Group; Participants in this group will receive guidance on healthy dietary habits and exercise methods. They will be informed that after 24 weeks of selection, they will have the option to choose HIIT exercise program or home training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in composite cardiovascular disease risk score (z-score)	The 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.	through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical and metabolic indicators	Biochemical indicators including GLU(mmol/L),CHO(mmol/L),TG(mmol/L),LDL-C(mmol/L),HDL-C(mmol/L) etc.	through study completion, an average of 2 year
CPET (Cardiopulmonary Exercise Testing) related indicators	Peak oxygen uptake（ml/min）	through study completion, an average of 2 year
calf circumference, waist circumference, and hip circumference	Indicators in terms of length include: calf circumference, waist circumference, and hip circumference	through study completion, an average of 2 year
Oral Glucose Tolerance Test (OGTT) Related Indicators	Fasting Blood Glucose and Insulin, 30-minute Postprandial Blood Glucose and Insulin, 120-minute Postprandial Blood Glucose and Insulin.	through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Beijing Chao Yang Hospital; Guangdong Provincial People's Hospital; Qingdao Municipal Hospital; Peking University Shenzhen Hospital; The First Affiliated Hospital of Shanxi Medical University
• Investigators: Principal Investigator: Yi-Da Tang, MD, PhD, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: metabolic syndrome; insufficient exercise
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: M2024315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No