Strategies for Proactive Health in People With Kidney Function Decline

NCT ID: NCT07245186

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2029-12-30

Brief Summary

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.

Detailed Description

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.

Conditions

Renal Insufficiency,Chronic; Dietary Intake Patterns; Malnutrition; Frailty; Cognitive Dysfunction; CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Non-dialysis patients with chronic kidney disease (CKD) stages 1-5.

2. Aged 18 to 90 years, no restriction on gender.

3. Sufficient health literacy or a family member with adequate literacy to comply with dietary diary recording and other study procedures.

4. Stable primary disease of CKD at the time of enrollment.

Exclusion Criteria

1. Patients with malignancies, severe cardiovascular diseases, osteoporosis, or severe hematological disorders.

2. Active infections (CRP >10 mg/L) or current use of nephrotoxic drugs.

3. Limb paralysis or amputation.

4. Use of immunosuppressants (cyclosporine, tacrolimus) within the past 3 months or steroid therapy equivalent to prednisone >10 mg/day.

5. Severe gastrointestinal diseases affecting nutrient absorption.

6. Participation in other diet- or drug-related clinical studies within the past month or ongoing.

7. Any other condition deemed inappropriate for participation by the investigators.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jingan District Central Hospital of Shanghai (Jingan Branch of Huashan Hospital Affiliated to Fudan University)

UNKNOWN

Sponsor Role: collaborator

Shanghai Changfeng community Healthcare center, Putuo, Shanghai, China

UNKNOWN

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chen Jing

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing Chen, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

Huashan hospital, Fudan university

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

KY2023-973

Identifier Type: -

Identifier Source: org_study_id