An exploratory study on the consistency and temporal variation of renal function of T2DM patients over time.

Study type
Protocol
Date of Approval
Study reference ID
17_231
Lay Summary

Chronic Kidney Disease can affect as much as half of patients with a particular type of diabetes, type 2 diabetes mellitus (T2DM). Nevertheless, kidney disease progression is not fully understood in T2DM as evidence has indicated that improvement of kidney function is also possible. Kidney function is often an important parameter when treatment decisions in T2DM are to be made, as only very few anti-diabetic treatments can be used safely in patients with kidney disease without requiring a dose adjustment. Using data from The Clinical Practice Research Datalink, this study aims to monitor kidney function in a cohort of T2DM patients over a period of 5 years to generate evidence on the evolution and patterns of kidney function over a long period of time. Evidence from this study can contribute in raising general practitioners' awareness of patterns of kidney function when treatment decisions in T2DM are to be made.

Technical Summary

Renal disease is a common comorbidity in patients with Type II Diabetes Mellitus (T2DM) and therefore renal function should be taken into consideration when medications are to be prescribed. Adopting a retrospective cohort study design, the aim of the study is to characterise T2DM patients' renal status and generate evidence on patterns of renal function evolution over time. In particular, a cohort of newly diagnosed T2DM patients will be followed up over time and for up to 5 years to examine a) eGFR trend b) counts and percentages of patients who have transitioned into a higher category of renal function compared to baseline, c) counts and percentages of patients who had been in a different eGFR category than the one assigned at baseline during follow up d) mean number of different eGFR categories a patient is assigned to over time d) counts and percentages of patients with an eGFR < 60 mL/min/1.73 m2 at baseline who have their eGFR increased to eGFR > 60 mL/min/1.73 m2 during follow up.

Health Outcomes to be Measured

eGFR trend (mean, median, SD, min, max, IQR, 95% CI) over time; Counts and percentages of T2DM patients who have transitioned into a higher category of renal function compared to baseline over time; Counts and percentages of T2DM patients who have transitioned into a lower category of renal function compared to baseline over time.

Collaborators

Nafeesa Dhalwani - Chief Investigator - Evidera, Inc
Dionysios Spanopoulos - Corresponding Applicant - Eli Lilly & Co - UK
Brendan Barrett - Collaborator - Boehringer-Ingelheim - UK
Chris D Poole - Collaborator - Digital Health Labs Limited
Kamlesh Khunti - Collaborator - University of Leicester
Michael Busse - Collaborator - Boehringer-Ingelheim - UK
Toni Roman - Collaborator - Eli Lilly & Co - UK

Linkages

HES Admitted Patient Care