CARPE-DM (CARdiometabolic multi-morbidity and CKD-related outcomes: A clinical Practice rEsearch datalink observational study in Diabetes Mellitus)

Study type
Protocol
Date of Approval
Study reference ID
19_271
Lay Summary

Multimorbidity is the co-existence of two or more long-term conditions. Patients with both type 2 diabetes (T2DM) and coronary heart disease (CHD) or stroke, known as cardiometabolic multimorbidity, have a much higher risk of dying than those with only one of these conditions. We hypothesise that this type of multimorbidity may also increase the risk of chronic kidney disease (CKD) and deaths related to kidney failure. CKD is a very common and debilitating condition, where over time the kidneys gradually fail to function properly. It affects 32% of people over 75 years of age in the UK. Early diagnosis and treatment of CKD can prevent the disease from getting worse. We aim to assess how fast kidney function, measured by CKD diagnosis, dialysis, and routine tests, declines over 10 years in people with either T2DM only, CHD/stroke only, or T2DM and CHD/stroke (cardiometabolic multimorbidity). Creating a better understanding of the relationship between cardiometabolic multimorbidity and CKD will help health care workers identify patients at high risk of developing CKD, allowing them to provide a treatment plan that does not increase the risk of CKD.

Technical Summary

Although CKD has been extensively studied in relation to individual risk factors, its association with cardiometabolic multimorbidity (a combination of T2DM and CHD/stroke) is poorly understood.

The study objectives are to use real world data to explore the influence of cardiometabolic multimorbidity (T2DM and CHD/Stroke) on the trajectory of age-related decline in renal function and other kidney disease outcomes by:

Cardiometabolic Multimorbidity:
1) Describe primary (from CPRD) and secondary resource (from HES) use over time, by multimorbidity status, stratified by age, sex, and ethnicity, as measured by number of consultations in different settings (Objective 1).

CKD-related:
2) Assess time to development of severe CKD, as measured by a diagnosis of CKD or dialysis (Objective 2).
3) Assess time to all-cause and CKD-related mortality as measured by a diagnosis of CKD or dialysis (Objective 3).
4) Assess the relationship between prognostic factors, treatments (antidiabetic and cardiovascular medication) and severe CKD/CKD-related mortality (Objective 4).

We will use CPRD Gold and linked hospital episode statistics (HES) to investigate all adults (?18 years) registered in CPRD that have been diagnosed with: (i) cardiometabolic multimorbidity (ii) T2DM only; (iii) CHD/stroke only, during 01/01/2000-12/31/2018. The objectives will be achieved by combining descriptive statistics (rates, means, standard deviations/medians and IQR; objective 1) and time-varying flexible parametric survival methods (objective 2, 3 and 4).

Health Outcomes to be Measured

• primary (from CPRD) and secondary (from HES) resource use, as measured by number and mean rate of consultations
• time to development of severe CKD
• time to all-cause and CKD-related mortality
• relationship between prognostic factors, treatment (antidiabetic and cardiovascular medication) and severe CKD/CKD-related mortality

Collaborators

David Webb - Chief Investigator - Leicester Diabetes Centre
Sophia Abner - Corresponding Applicant - University of Leicester
Briana Coles - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Samuel Seidu - Collaborator - University of Leicester
Sharmin Shabnam - Collaborator - University of Leicester
Simona Boccaletti - Collaborator - Merck Sharp & Dohme - UK
Tobi Adeyemi - Collaborator - Merck Sharp & Dohme - UK

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data