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

NCT06528639 | Recruiting DMC

• 1 other identifier: M2024315
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; insufficient exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Biochemical and metabolic indicators

  through study completion, an average of 2 year

• CPET (Cardiopulmonary Exercise Testing) related indicators

  through study completion, an average of 2 year

• calf circumference, waist circumference, and hip circumference

  through study completion, an average of 2 year

• Oral Glucose Tolerance Test (OGTT) Related Indicators

  through study completion, an average of 2 year

Study Arms (2)

Individualized HIIT Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

HIIT BEHAVIORAL

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

Individualized HIIT Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Chao Yang Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Peking University Shenzhen Hospital: collaborator
• The First Affiliated Hospital of Shanxi Medical University: collaborator
• Qingdao Municipal Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Yi-Da Tang, MD, PhD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Gao, PhD

CONTACT

+86-10-82266697; puthxnk@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 30, 2024
• Study Start: May 21, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)