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| Name | Class |
|---|---|
| Jingan District Central Hospital of Shanghai (Jingan Branch of Huashan Hospital Affiliated to Fudan University) | UNKNOWN |
| Shanghai Changfeng community Healthcare center, Putuo, Shanghai, China | UNKNOWN |
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This prospective cohort study aims to investigate how kidney function decline affects multiple body systems and how personalized nutrition can help maintain health and slow disease progression. About 1,800 adults with reduced kidney function but not on dialysis will be followed over time at Huashan Hospital, Fudan University. The study will collect information on nutrition, heart and bone health, cognition, and daily functioning through hospital records and a patient mobile app. The goal is to understand the links between nutrition, metabolism, and organ function, and to develop integrated strategies for early prevention and management of chronic kidney disease.
Kidney function often declines gradually with age or chronic conditions, even before chronic kidney disease is formally diagnosed. This decline can disturb the body's overall balance, leading to changes in heart and blood vessel health, bone metabolism, muscle strength, and cognitive performance. Nutrition and metabolism play central roles in these processes, but how they interact during kidney function decline remains unclear.
This prospective cohort study, conducted at Huashan Hospital, Fudan University, aims to understand the multisystem changes that occur during kidney function decline and to explore how individualized, nutrition-integrated management can help maintain health and slow disease progression. Approximately 1,800 adults with an estimated glomerular filtration rate (eGFR) below 90 mL/min/1.73 m² and not receiving dialysis will be enrolled and followed for up to ten years.
Comprehensive information on participants' diet, biochemical markers, heart and bone health, cognition, and physical function will be collected through hospital systems and a mobile nutrition management app. The study seeks to identify how nutritional status and metabolic adaptation relate to outcomes such as kidney function decline, cardiovascular disease, frailty, and cognitive impairment. Findings from this research will help develop an integrated, multidisciplinary approach to prevent complications and improve the overall health and quality of life of people with reduced kidney function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with renal function decline (non-dialysis cohort) | This is a multi-center prospective cohort study led by Huashan Hospital, Fudan University, with collaboration from several other hospitals. The study aims to recruit at least1800 participants, primarily older adults, with varying degrees of kidney function decline, with enrollment ongoing from January 2021 to December 2029. Participants undergo baseline assessments, including dietary intake surveys, biochemical and metabolic testing, body composition analysis, and clinical evaluations. Follow-up assessments are conducted at predetermined intervals to monitor kidney function, cardiovascular health, metabolic status, and overall well-being. This cohort provides a structured platform for long-term observational research on the relationship between nutrition, metabolism, and health outcomes in aging populations. The findings will support the development of precision nutrition strategies and proactive aging health management. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rapid decline in renal function | The primary outcome is the occurrence of a rapid decline in kidney function, defined as a ≥40% decrease in estimated glomerular filtration rate (eGFR) from baseline during the follow-up period. eGFR will be calculated using the CKD-EPI formula based on serum creatinine measurements obtained during scheduled clinical visits. | eGFR will be measured at baseline and at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, and 36 months after enrollment, and subsequently every 6 months thereafter up to 10 years of follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| End-Stage Renal Disease (ESRD) | The occurrence of end-stage renal disease (ESRD), defined as initiation of renal replacement therapy, including maintenance dialysis (hemodialysis or peritoneal dialysis) or receipt of kidney transplantation. ESRD events will be confirmed through clinical records and verified by treating nephrologists. | Assessed at baseline and every follow-up visit (1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months, and every 6 months thereafter up to 10 years). |
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Inclusion Criteria:
Exclusion Criteria:
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Adults aged 18 years or older with reduced kidney function (eGFR < 90 mL/min/1.73 m²) who are not receiving dialysis. Participants are recruited from outpatient clinics at Huashan Hospital, Fudan University.
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| Name | Affiliation | Role |
|---|---|---|
| Jing Chen, PhD, MD | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan hospital, Fudan university | Shanghai | Shanghai Municipality | 20040 | China |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D044342 | Malnutrition |
| D000073496 | Frailty |
| D060825 | Cognitive Dysfunction |
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Incidence of Cardiovascular Events | Composite incidence of cardiovascular and cerebrovascular events, including coronary artery disease, cardiac arrhythmia, stroke, heart failure, and sudden cardiac death. All events will be confirmed through medical records, imaging examinations, and classified according to international diagnostic standards. | Evaluated at baseline, at 6 months, at 1 year, and annually thereafter up to 10 years. |
| All-Cause Mortality | All-cause mortality includes death due to any cause, with a specific focus on deaths related to kidney disease progression and its complications, particularly cardiovascular disease, infections, and other related conditions. Deaths will be verified through medical records and official documentation. | Assessed at baseline and every follow-up visit (1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months, and every 6 months thereafter up to 10 years). |
| Cognitive Impairment | Cognitive function will be assessed using the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA). MMSE scores <27 and MoCA scores <26 indicate cognitive impairment. Severity will be classified as mild, moderate, or severe based on standardized score ranges and adjusted for education level. | Evaluated at baseline, 12 months, 24 months, 36 months, and every 2 years thereafter up to 10 years. |
| Frailty | Frailty will be determined using the Fried frailty phenotype, defined by the presence of three or more of the following criteria: unintentional weight loss (≥4.5 kg or ≥5% within one year), self-reported exhaustion, weakness (grip strength adjusted for sex and BMI), slow walking speed (adjusted for sex and height), and low physical activity level assessed by the Minnesota Leisure Time Activity Questionnaire. | Measured at baseline, 12 months, 24 months, 36 months, and every 2 years thereafter up to 10 years. |
| Malnutrition and Protein-Energy Wasting (PEW) | Nutritional status will be evaluated according to both the GLIM criteria and the ISRNM definition of protein-energy wasting (PEW). GLIM diagnosis requires at least one phenotypic criterion (unintentional weight loss, low BMI, or reduced muscle mass by BIA or ultrasound) and one etiologic criterion (reduced food intake/absorption or disease burden/inflammation). PEW is defined by abnormalities in at least three of four domains: biochemical markers, body composition, muscle mass, and dietary intake, according to ISRNM standards. | Assessed at baseline, 6 months, 12 months, 24 months, 36 months, and every 12 months thereafter up to 10 years. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |