We aim to investigate whether people who live with obesity and are diagnosed with chronic kidney disease (CKD) can delay progression of chronic kidney disease by losing weight after their CKD diagnosis. CKD means that the kidneys are damaged and cannot filter blood the way they should. Obesity can cause CKD and can also worsen chronic kidney disease more quickly, because increased body weight puts more workload on the kidneys. Because the prevalence of obesity is increasing worldwide, a growing number of people will be at risk for developing CKD in the future. If this study finds that weight loss in CKD patients living with obesity can slow disease progression, it could guide and motivate patients and their treating physicians in developing appropriate treatment plans at the time of diagnosis with CKD.
The overarching aim of this retrospective cohort study is to investigate whether people with obesity who are diagnosed with chronic kidney disease (CKD) can delay kidney disease progression by losing weight after their diagnosis. We will compare patients who lived with obesity (BMI ≥30) when they were diagnosed with CKD and then either intentionally lost 10-35% of their body weight within the two years after their diagnosis or maintained (±2.9%) or increased (≥3%) their body weight within the two years after their diagnosis. The primary outcome will be time to a composite CKD endpoint based on the recent consensus guidelines for kidney disease: eGFR <15ml/min/1.73m² persisting for 3 months or more, OR single eGFR drop <15ml/min/1.73m² and then dialysis (>28 days) or kidney transplant, OR ≥40% percent decline in eGFR from baseline and sustained over at least 4 weeks, OR death with chronic kidney disease as the underlying cause of death, whichever occurs first. Secondary outcomes will be components of the composite CKD endpoint. All endpoints will be analysed using Cox proportional hazards regression. CPRD Aurum Hospital Episode Statistics (HES) outpatient data will be used to determine dialysis events as part of the primary outcome. HES admission data will be used to determine kidney related outcomes and procedures, contributing to the ascertainment of the primary outcome, and ONS Death Registration Data will be used to determine whether the underlying cause of death is kidney-related, which also contributes to the primary outcome. Practice and patient level index of multiple deprivation will be used to account for differences in socioeconomic status and as a proxy for quality of care. The intended public health benefit is that the information on the effect of weight loss after CKD diagnosis can guide patients with obesity and CKD and their treating physicians when discussing treatment strategies.
Primary outcome: Composite CKD outcome based on eGFR <15ml/min/1.73m² persisting for 3 months or more, OR single eGFR drop <15ml/min/1.73m² and then dialysis (>28 days) or kidney transplant, OR ≥40% percent decline in eGFR from baseline and sustained over at least 4 weeks, OR death with chronic kidney disease as the underlying cause of death, whichever occurs first.
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Secondary outcomes: (1) Components of composite outcome, (2) Single eGFR drop <15ml/min/1.73m² followed by all-cause death within the next 6 months
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Exploratory outcomes: Healthcare resource utilisation: number of primary care provider contacts, number of outpatient clinic contacts, number of prescriptions, length of hospital stay, number of hospital admissions within the first 3 years of follow-up.
Maximiliane Verfürden - Chief Investigator - Novo Nordisk A/S
Maximiliane Verfürden - Corresponding Applicant - Novo Nordisk A/S
David Wheeler - Collaborator - University College London ( UCL )
Morten Rix Hansen - Collaborator - Novo Nordisk A/S
SHWETA UPPAL - Collaborator - Novo Nordisk A/S
Silvia Capucci - Collaborator - Novo Nordisk A/S
Volker Schnecke - Collaborator - Novo Nordisk A/S
HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation