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| ID | Type | Description | Link |
|---|---|---|---|
| MR-11-25-027504 | Registry Identifier | National Universal Health Assurance Information Platform - Medical Research Registration and Filing Information System |
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Cardiovascular-Kidney-Metabolic (CKM) syndrome underscores the pathophysiologic interplay among metabolic risk factors, chronic kidney disease (CKD) and the cardiovascular system. This crosstalk precipitates multi-organ dysfunction, increases adverse cardiovascular events, and imposes heavy familial and socioeconomic burdens. Building a health-management platform within research wards is therefore urgent. Such a platform is the pivotal venue for assessment, monitoring, intervention and follow-up in continuous care.
Leveraging the existing health-management system of the Health Screening Center at Peking University Third Hospital, the investigators will develop a comprehensive CKM platform that integrates systemic inflammatory biomarkers, cardiovascular early-warning algorithms, and personalized diet-and-exercise prescriptions. The system will provide cyclic management encompassing evaluation, guidance, monitoring, feedback and longitudinal follow-up.
A randomized controlled trial with two-year prospective follow-up will enroll patients at CKM stages 0-2 to evaluate clinical improvement, quality of life, dietary behavior and physical activity after platform enrollment. The project will enable early identification of high-risk individuals, deliver precision management, maximize data utility, and offer a novel research-ward model that addresses mobile-health pain points and closes the CKM care loop.
1.Construction of a Comprehensive CKM Health-Management Platform
2. Deployment and feasibility evaluation CKM stage 0-2 patients meeting diagnostic criteria will receive two-year comprehensive management via the platform. Clinical metrics and quality-of-life indices will be used to evaluate feasibility, early identification of high-risk individuals, improvement of composite CKM endpoints and patient-centred outcomes.
3. Innovation highlights This project will deliver the first Chinese integrated health-information platform dedicated to CKM syndrome. It unites systemic inflammatory biomarkers, cardiovascular (early-warning) algorithms and individualised diet/exercise modules into one (closed-loop) system that continuously monitors, profiles, analyses, risk-stratifies, manages and follows each patient. Multi-dimensional data (physiology, lifestyle, genetics) feed an individualised management cycle of "monitor-profile-analyse-risk-score-intervene-follow-up", offering a novel methodologic and theoretical framework for early risk detection and precision intervention in CKM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Enrolled into a comprehensive health-management platform for cardiorenal metabolic syndrome and received integrated management for 2 years. |
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| Control Arm | Active Comparator | The control group receives routine post-examination follow-up and health management provided by the health check-up center. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Health Management Platform | Behavioral | The health-management programme comprises:
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| Measure | Description | Time Frame |
|---|---|---|
| Height | Body height measured in centimeters using a height and weight measuring instrument. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Weight | Body weight measured in kilograms using a height and weight measuring instrument. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Systolic Blood Pressure | Systolic blood pressure measured in millimeters of mercury (mmHg) using an automated sphygmomanometer after 5 minutes of rest. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Diastolic Blood Pressure | Diastolic blood pressure measured in millimeters of mercury (mmHg) using an automated sphygmomanometer after 5 minutes of rest. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Heart Rate on 12-Lead Electrocardiogram | Heart rate measured in beats per minute (bpm) from 12-lead electrocardiogram recorded after 10 minutes of rest in supine position. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| PR Interval on 12-Lead Electrocardiogram | PR interval measured in milliseconds (ms) from 12-lead electrocardiogram. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| QRS Duration on 12-Lead Electrocardiogram |
| Measure | Description | Time Frame |
|---|---|---|
| White Blood Cell Count | White blood cell count measured in 10^9 cells per liter (10^9/L) using automated hematology analyzer. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Red Blood Cell Count |
| Measure | Description | Time Frame |
|---|---|---|
| Score on International Physical Activity Questionnaire-Short Form (IPAQ-SF) | Physical activity level assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), a 7-item self-administered questionnaire measuring the frequency and duration of vigorous-intensity activity, moderate-intensity activity, and walking during the past 7 days. Total physical activity is calculated as metabolic equivalent of task (MET)-minutes per week, categorized as low (<600 MET-min/week), moderate (600-3000 MET-min/week), or high (>3000 MET-min/week) activity level. Higher MET-minutes indicate higher physical activity level. Reported as mean total MET-minutes per week and number of participants in each activity category at each assessment time point. |
Inclusion Criteria:
Exclusion Criteria:
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| Post-examination follow-up management | Other | Post-examination report interpretation service and telephone follow-up for patients with abnormal findings. |
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QRS duration measured in milliseconds (ms) from 12-lead electrocardiogram. Reported as mean value at each assessment time point. |
| Baseline, Month 12, Month 24 |
| QTc Interval on 12-Lead Electrocardiogram | Corrected QT interval (QTc) measured in milliseconds (ms) using Bazett's formula from 12-lead electrocardiogram. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Left Ventricular Ejection Fraction (LVEF) | Left ventricular ejection fraction measured as percentage (%) using two-dimensional echocardiography with Simpson's biplane method. Higher values indicate better cardiac function. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Left Ventricular End-Diastolic Diameter (LVEDD) | Left ventricular end-diastolic diameter measured in millimeters (mm) using M-mode echocardiography. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Lactate Dehydrogenase (LDH) | Serum lactate dehydrogenase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Alpha-Hydroxybutyrate Dehydrogenase (α-HBDH) | Serum alpha-hydroxybutyrate dehydrogenase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Creatine Kinase (CK) | Serum creatine kinase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Creatine Kinase-MB (CK-MB) | Serum creatine kinase-MB isoenzyme activity measured in units per liter (U/L) using immunoinhibition assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point. | Baseline, Month 12, Month 24 |
| Urine Occult Blood | Presence of occult blood in urine detected using dipstick method. Reported as number and percentage of participants with positive result (1+ or greater) at each assessment time point. | Baseline, Month 12, Month 24 |
| Urine Protein | Presence of protein in urine detected using dipstick method. Reported as number and percentage of participants with positive result (1+ or greater) at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Total Bilirubin | Serum total bilirubin concentration measured in micromoles per liter (μmol/L) using diazo method. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Total Protein | Serum total protein concentration measured in grams per liter (g/L) using biuret method. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Albumin | Serum albumin concentration measured in grams per liter (g/L) using bromocresol green method. Reported as mean value and number of participants with values below lower limit of normal (LLN) at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Direct Bilirubin | Serum direct (conjugated) bilirubin concentration measured in micromoles per liter (μmol/L) using diazo method with caffeine accelerator. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Activity of Aspartate Aminotransferase (AST) | Serum aspartate aminotransferase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point. | Baseline, Month 12, Month 24 |
| Activity of Alanine Aminotransferase (ALT) | Serum alanine aminotransferase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Globulin | Serum globulin concentration calculated as the difference between total protein and albumin concentrations, measured in grams per liter (g/L). Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Uric Acid | Serum uric acid concentration measured in micromoles per liter (μmol/L) using uricase method. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point. | Baseline, Month 12, Month 24 |
| Estimated Glomerular Filtration Rate (eGFR) | Estimated glomerular filtration rate calculated in milliliters per minute per 1.73 square meters (mL/min/1.73m²) using CKD-EPI equation based on serum creatinine and cystatin C. Higher values indicate better kidney function. Reported as mean value and number of participants with eGFR <60 mL/min/1.73m² at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Total Cholesterol | Serum total cholesterol concentration measured in millimoles per liter (mmol/L) using enzymatic colorimetric assay after overnight fasting. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Triglycerides | Serum triglyceride concentration measured in millimoles per liter (mmol/L) using enzymatic glycerol phosphate oxidase method after overnight fasting. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Low-Density Lipoprotein Cholesterol (LDL-C) | Serum LDL-C concentration measured in millimoles per liter (mmol/L) using direct enzymatic assay or calculated using Friedewald formula after overnight fasting. Lower values indicate better cardiovascular risk profile. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of High-Density Lipoprotein Cholesterol (HDL-C) | Serum HDL-C concentration measured in millimoles per liter (mmol/L) using direct enzymatic assay after overnight fasting. Higher values indicate better cardiovascular risk profile. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Fasting Plasma Glucose | Fasting plasma glucose concentration measured in millimoles per liter (mmol/L) using hexokinase method after at least 8 hours of fasting. Reported as mean value and number of participants with values ≥7.0 mmol/L at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Glycated Hemoglobin (HbA1c) | HbA1c level measured as percentage (%) using high-performance liquid chromatography (HPLC) method standardized to National Glycohemoglobin Standardization Program (NGSP). Lower values indicate better glycemic control. Reported as mean value and number of participants with HbA1c ≥6.5% at each assessment time point. | Baseline, Month 12, Month 24 |
Red blood cell count measured in 10^12 cells per liter (10^12/L) using automated hematology analyzer. Reported as mean value at each assessment time point.
| Baseline, Month 12, Month 24 |
| Hemoglobin Concentration | Hemoglobin concentration measured in grams per liter (g/L) using cyanmethemoglobin method. Reported as mean value and number of participants with values below lower limit of normal (LLN) at each assessment time point. | Baseline, Month 12, Month 24 |
| Platelet Count | Platelet count measured in 10^9 cells per liter (10^9/L) using automated hematology analyzer. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Urine Red Blood Cell Coun | Red blood cell count in urine measured in cells per high-power field (cells/HPF) using microscopic examination of centrifuged urine sediment. Reported as mean value and number of participants with values above 3 cells/HPF at each assessment time point. | Baseline, Month 12, Month 24 |
| Urine White Blood Cell Count | White blood cell count in urine measured in cells per high-power field (cells/HPF) using microscopic examination of centrifuged urine sediment. Reported as mean value and number of participants with values above 5 cells/HPF at each assessment time point. | Baseline, Month 12, Month 24 |
| Urine Bacterial Count | Bacterial count in urine measured in colony-forming units per milliliter (CFU/mL) using quantitative urine culture. Reported as number and percentage of participants with bacterial count ≥10^5 CFU/mL at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Serum Creatinine | Serum creatinine concentration measured in micromoles per liter (μmol/L) using enzymatic method. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Fasting Insulin | Serum fasting insulin concentration measured in picomoles per liter (pmol/L) or microunits per milliliter (μIU/mL) using chemiluminescent immunoassay after at least 8 hours of fasting. Reported as mean value and calculated Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Serum C-Peptide | Serum C-peptide concentration measured in nanomoles per liter (nmol/L) or nanograms per milliliter (ng/mL) using chemiluminescent immunoassay after at least 8 hours of fasting. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of 25-Hydroxyvitamin D [25(OH)D] | Serum 25-hydroxyvitamin D concentration measured in nanomoles per liter (nmol/L) or nanograms per milliliter (ng/mL) using chemiluminescent immunoassay (CLIA) or liquid chromatography-tandem mass spectrometry (LC-MS/MS). 25(OH)D is the major circulating form of vitamin D and reflects vitamin D status. Higher values indicate better vitamin D sufficiency. Reported as mean value and number of participants with 25(OH)D <50 nmol/L (20 ng/mL) indicating deficiency, 50-75 nmol/L (20-30 ng/mL) indicating insufficiency, and ≥75 nmol/L (30 ng/mL) indicating sufficiency at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Interleukin-6 (IL-6) | Serum interleukin-6 concentration measured in picograms per milliliter (pg/mL) using high-sensitivity enzyme-linked immunosorbent assay (ELISA) or chemiluminescent immunoassay. IL-6 is a pro-inflammatory cytokine. Lower values indicate lower systemic inflammation. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Interleukin-10 (IL-10) | Serum interleukin-10 concentration measured in picograms per milliliter (pg/mL) using enzyme-linked immunosorbent assay (ELISA) or chemiluminescent immunoassay. IL-10 is an anti-inflammatory cytokine. Higher values may indicate compensatory anti-inflammatory response. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Interleukin-1β (IL-1β) | Serum interleukin-1β concentration measured in picograms per milliliter (pg/mL) using high-sensitivity enzyme-linked immunosorbent assay (ELISA). IL-1β is a key pro-inflammatory cytokine. Lower values indicate lower systemic inflammation. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of Tumor Necrosis Factor-alpha (TNF-α) | Serum tumor necrosis factor-alpha concentration measured in picograms per milliliter (pg/mL) using high-sensitivity enzyme-linked immunosorbent assay (ELISA) or chemiluminescent immunoassay. TNF-α is a major pro-inflammatory cytokine. Lower values indicate lower systemic inflammation. Reported as mean value at each assessment time point. | Baseline, Month 12, Month 24 |
| Concentration of High-Sensitivity C-Reactive Protein (hs-CRP) | Serum high-sensitivity C-reactive protein concentration measured in milligrams per liter (mg/L) using immunoturbidimetric assay or nephelometry. hs-CRP is an acute-phase reactant and marker of systemic inflammation. Lower values indicate lower cardiovascular risk and systemic inflammation. Reported as mean value and number of participants with hs-CRP <1 mg/L (low risk), 1-3 mg/L (moderate risk), and >3 mg/L (high risk) for cardiovascular disease at each assessment time point. | Baseline, Month 12, Month 24 |
| Baseline, Month 12, Month 24 |
| Score on 36-Item Short Form Health Survey (SF-36) | Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36), a 36-item self-administered questionnaire measuring eight health domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). Each domain score ranges from 0 to 100, with higher scores indicating better health status. Two summary component scores are calculated: Physical Component Summary (PCS) and Mental Component Summary (MCS). Reported as mean scores for each domain and summary components at each assessment time point. | Baseline, Month 12, Month 24 |