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NCT07906405

Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia

Sponsor: Dacima Consulting

View on ClinicalTrials.gov

Summary

The TUN-CKDN study is a national, multicenter, prospective cohort study conducted in nephrology centers in Tunisia. It aims to describe how often malnutrition and sarcopenia (loss of muscle strength and muscle mass) occur in adults with chronic kidney disease (CKD) stages G3a to G5D, including patients not on dialysis and patients treated by hemodialysis or peritoneal dialysis, and whether these conditions are linked to future health outcomes. At inclusion, each participant will undergo a standardized nutritional and muscle assessment as part of routine care: medical history, physical activity questionnaire, clinical examination, body weight and height, body composition by bioelectrical impedance analysis (or calf circumference when impedance cannot be performed), a chair-stand test for muscle strength, a 4-meter walking speed test, routine blood tests, and a detailed dietary interview conducted by a trained dietitian. Malnutrition will be defined using the Global Leadership Initiative on Malnutrition (GLIM) criteria and sarcopenia using the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria. The Malnutrition-Inflammation Score (MIS) will also be calculated. Participants available at 2 years will have the same nutritional and muscle assessment repeated. All participants will be followed at 2 and 5 years to record kidney outcomes (start of dialysis or kidney transplantation in patients not on dialysis at inclusion), major cardiovascular events, hospitalizations, and deaths. The study does not involve any treatment or change in usual medical care. About 4,000 participants are planned.

Official title: Nutritional Status, Muscle Phenotype, and Clinical Outcomes in Tunisian Patients With Chronic Kidney Disease: a National Multicenter Prospective Cohort Study (TUN-CKDN)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

4000

Start Date

2026-11-15

Completion Date

2032-09-30

Last Updated

2026-10-30

Healthy Volunteers

No

Interventions

OTHER

Standardized nutritional and muscle assessment

No treatment is administered and usual care is not modified. Assessment performed as part of the study: clinical nutritional examination, anthropometry, bioelectrical impedance analysis (or calf circumference when impedance is unavailable), five-times sit-to-stand test, 4-meter gait speed, routine laboratory tests, physical activity questionnaire (IPAQ-SF) and dietary history by a trained dietitian (baseline only).

Locations (1)

Hôpital Militaire Principal d'Instruction de Tunis, Department of Nephrology

Tunis, Tunisia