Rate and risk of cardiovascular events and all-cause mortality in individuals with type 2 diabetes, with and without microalbuminuria - a cohort study in the CPRD database

Date of ISAC Approval: 
01/06/2018
Lay Summary: 
Diabetes Mellitus is a chronic metabolic disorder (an abnormal chemical reaction in the body altering the normal process of properly utilizing and/or storing energy) which occurs due to insufficient insulin production and/or insulin resistance. Type 2 diabetes mellitus (T2DM) is the most common form of the condition, accounting for approximately 90% of all diagnosed cases worldwide. The prevalence of diabetes is increasing in the UK and worldwide. Diabetes can cause many health complications including heart disease, stroke, chronic kidney disease, eye disease and foot ulcers. People with T2DM have high risk of microalbuminuria (leakage of protein in kidneys) which is associated with worsening kidney function (an indication of the kidney's condition), cardiovascular disease (heart disease) and mortality. This study aims to estimate the overall cardiovascular, declining of renal function and mortality rates in people with T2DM and microalbuminuria, compared to those with T2DM alone. This study will also explore the association of microalbuminuria with cardiovascular, declining of renal function and mortality in people with T2DM. This study will provide useful information about the numbers of cardiovascular, renal and mortality events in T2DM patients and will quantify the additional burden of microalbuminuria.
Technical Summary: 
The potential high risk of cardiovascular events and mortality in T2DM patients with/without microalbuminuria, has not been fully evaluated. This study aims to estimate the overall cardiovascular, renal disease and mortality rates in people with T2DM with/without microalbuminuria. The study will also explore whether there is an association between microalbuminuria and cardiovascular risk and mortality in a real-world setting of people with T2DM. All T2DM patients will be included in this study diagnosed between 01-Jan-2008 and 31-Dec-2012. Time-to-event analysis will be conducted with adjustment for a wide range of confounders including demographics, lifestyle variables, prescriptions and deprivation category. Linked external datasets will contribute to evaluation of cardiovascular outcomes and causes of deaths. This study will provide useful information about the rate and risk of cardiovascular and renal events and all-cause mortality in T2DM individuals with and without microalbuminuria.
Health Outcomes to be Measured: 
- Cardiovascular events (composite endpoint of myocardial infarction, stroke and cardiovascular death) - Renal events (composite endpoint of new-onset of macroalbuminuria, doubling of the serum creatinine level, end-stage renal disease, or death due to renal disease) - Mortality and causes of death
Collaborators: 

Professor Kamlesh Khunti - Chief Investigator - University Of Leicester
Dr Clare Gillies - Collaborator - University Of Leicester
Dr Francesco Zaccardi - Collaborator - University Of Leicester
Professor Melanie Davies - Collaborator - University Of Leicester
Mr Usman Muhammad - Corresponding Applicant - University Of Leicester

Linkages: 
HES Admitted;ONS;Patient IMD