Assessment of the burden of chronic kidney disease (CKD) in patients with type 2 diabetes (T2D) in England

Study type
Protocol
Date of Approval
Study reference ID
20_000167
Lay Summary

Chronic Kidney Disease (CKD) is defined as a progressive, irreversible loss of kidney function that usually happens gradually over years. Patients with CKD commonly have other chronic conditions as well, including type-2 diabetes (T2D) and cardiovascular diseases. Having both CKD and T2D greatly increases ill-health and mortality of patients. There is little information about the real-world characteristics and management of patients with both CKD and T2D in England. This study addresses this data gap by collecting data on the characteristics, treatment, and outcomes for patients with both CKD and T2D in England.

Technical Summary

This study is aimed at determining the burden of chronic kidney disease (CKD) in the type-2 diabetes population of England including prevalence, treatment patterns, and occurrence of cardiovascular and renal complications. Prevalence of CKD in the T2D population of England will be determined at seven cross-sectional time points, at six month intervals, from January 2017 to December 2019. Demographics, cardiovascular and renal medication use, and history of CKD investigations will be assessed in each cohort from each of the seven time points. Additionally, a cohort study covering the entire period from January 2017 to December 2019 will be assessed for the occurrence of cardiovascular and renal complications and for the occurrence of side effects related to treatment with mineralocorticoid receptor antagonist (MRA). Incidence of these events will be determined using Poisson regression and cumulative incidence using Kaplan-Meier curves. These outcomes will be assessed in the CKD-T2D population and in a number of subgroups, including patients meeting specific inclusion/exclusion criteria related to their CKD and those patients with a history of cardiovascular disease, taking specific cardiovascular or renal medications, a chronic respiratory diseases.

Health Outcomes to be Measured

Prevalence of CKD in T2D population
Incidence and cumulative incidence of cardiovascular/renal complications and side-effects of MRA use

Collaborators

Jennifer Quint - Chief Investigator - Imperial College London
- Corresponding Applicant -
Julie Broughton - Collaborator - Bayer AG
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Niklas Schmedt - Collaborator - Bayer AG
Philip Kalra - Collaborator - Salford Royal Hospital NHS Foundation

Linkages

HES Accident and Emergency;HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation