Metabolic syndrome, including components such as hypertension, dyslipidemia (elevated triglycerides, low HDL-C), impaired glucose regulation (elevated fasting glucose or HbA1c), and abdominal obesity. The study population consists of middle-aged adults at high risk of cardiometabolic disorders, aiming to evaluate the efficacy of exercise interventions for cardiometabolic risk reduction and disease prevention. Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 15/09/2025: 1. Adults aged 40 to 65 years 2. Diagnosed with metabolic syndrome based on at least three of the following criteria (as per IDF or Chinese guidelines): 2.1. Elevated waist circumference 2.2. Elevated triglycerides (=150 mg/dL) 2.3. Reduced HDL cholesterol (<40 mg/dL for men, <50 mg/dL for women) 2.4. Elevated blood pressure (SBP =130 mmHg or DBP =85 mmHg) 2.5. Elevated fasting blood glucose (=100 mg/dL) 3. Able and willing to provide written informed consent 4. Physically capable of participating in supervised moderate-to-high intensity exercise programs 5. No change in medication for at least 3 months prior to enrolment _____ Previous inclusion criteria: 1. Adults aged 40 to 60 years 2. Diagnosed with metabolic syndrome based on at least three of the following criteria (as per IDF or Chinese guidelines): 2.1. Elevated waist circumference 2.2. Elevated triglycerides (=150 mg/dL) 2.3. Reduced HDL cholesterol (<40 mg/dL for men, <50 mg/dL for women) 2.4. Elevated blood pressure (SBP =130 mmHg or DBP =85 mmHg) 2.5. Elevated fasting blood glucose (=100 mg/dL) 3. Able and willing to provide written informed consent 4. Physically capable of participating in supervised moderate-to-high intensity exercise programs 5. No change in medication for at least 3 months prior to enrolment
Exclusion criteria
Exclusion criteria: 1. Diagnosed with severe cardiovascular disease (e.g., unstable angina, recent myocardial infarction within 6 months) 2. Diagnosed with severe pulmonary disease or respiratory insufficiency 3. Diagnosed with advanced liver or renal dysfunction 4. History of stroke or other neurological disorders affecting motor ability 5. Musculoskeletal disorders or injuries preventing safe exercise participation 6. Currently receiving chemotherapy, radiotherapy, or immunosuppressive treatment 7. Diagnosed psychiatric illness or cognitive impairment that limits informed consent or compliance 8. Participation in any other clinical trial within the past 3 months 9. Pregnancy or planning to become pregnant during the study period 10. Refusal or inability to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fasting blood glucose (FBG) and glycated hemoglobin (HbA1c) levels were measured using standardized venous blood assays in a central laboratory from at baseline (T1), mid-intervention (T2, week 6), and post-intervention (T3, week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures were conducted using standardized protocols under blinded laboratory conditions. Intermediate measurements were taken at week 6 to observe dynamic responses to intervention: 1. Change in triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) levels measured using fasting venous blood samples in a central laboratory from baseline to week 12 2. Change in body mass index (BMI), calculated from measured weight and height, assessed at baseline, week 6, and week 12 3. Change in serum alanine aminotransferase (ALT) levels, used as a marker of liver function, measured using standardized procedures from baseline to week 12 4. Change in serum uric acid (UA) levels measured using biochemical assays from baseline to week 12 5. Change in high-sensitivity C-reactive protein (hs-CRP) levels, as an index of systemic inflammation, measured using standardized procedures from baseline to week 12 6. Change in heart rate recovery (HRR), defined as the drop in heart rate within 1 minute after exercise cessation, and measured using Polar H10 monitors at week 0, 6, and 12 | — |
Countries
China