Burden of Chronic Kidney Disease (CKD), Type 2 Diabetes Mellitus (T2DM), and Comorbid T2DM/CKD in Alberta, Canada

NCT ID: NCT04417725

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

588170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-01

Study Completion Date

2022-08-31

Brief Summary

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The purpose of the research study is to describe the burden of disease among three different cohorts of patients: (1) patients diagnosed with CKD, (2) those with T2DM; and (3) those with T2DM and comorbid CKD.

Detailed Description

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Chronic kidney disease (CKD) has been ranked as the 10th leading cause of death in Canada as of 2013, while type 2 diabetes mellitus (T2DM) is one of the fastest growing diseases in Canada. There is a growing body of evidence that has examined these populations in real-world settings in Canada. The study described below will add to the growing body of literature that has examined CKD patients in Alberta and will contribute to an understanding of the epidemiology of CKD by stage, as well as healthcare resource utilization (HCRU) and costs. Furthermore, this study will contribute to a more nuanced understanding of the epidemiology, treatment patterns, HCRU and costs, and adverse events for T2DM patients with and without comorbid CKD in Alberta.

Conditions

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Chronic Kidney Diseases Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Chronic kidney disease

Adult patients (≥18 years of age) with CKD were identified in Alberta during the case ascertainment period (April 1, 2010, to March 31, 2019), based on a validated algorithm incorporating ICD-9-CM/ICD-10-CA coding, estimated glomerular filtration rate, and albuminuria laboratory tests. This is a non-interventional, observational study, and thus, no intervention was administered.

Not applicable - this is a non-interventional, observational study.

Intervention Type OTHER

Not applicable - this is a non-interventional, observational study.

Type 2 diabetes mellitus

Adult patients with T2DM were identified in Alberta during the case ascertainment period (April 1, 2010 to March 31, 2018), based on a validated algorithm incorporating ICD-9-CM and ICD-10-CA codes. This is a non-interventional, observational study, and thus, no intervention was administered.

Not applicable - this is a non-interventional, observational study.

Intervention Type OTHER

Not applicable - this is a non-interventional, observational study.

Comorbid type 2 diabetes mellitus and chronic kidney disease

The derived T2DM cohort was used to identify patients with comorbid T2DM/CKD (stages 1-3) during the same case ascertainment period (April 1, 2010 to May 31, 2018). The study cohort included T2DM patients with comorbid CKD (stages 1-3) identified in Alberta within the two years prior or after their T2DM index date, using the T2DM index date as the index date for this cohort. This is a non-interventional, observational study, and thus, no intervention was administered.

Not applicable - this is a non-interventional, observational study.

Intervention Type OTHER

Not applicable - this is a non-interventional, observational study.

Interventions

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Not applicable - this is a non-interventional, observational study.

Not applicable - this is a non-interventional, observational study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Chronic kidney disease identified using laboratory test and health administrative data
* Type 2 diabetes mellitus identified using health administrative data

Exclusion Criteria

* Age \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medlior Health Outcomes Research Ltd

OTHER

Sponsor Role lead

Responsible Party

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Tara Cowling

Director and Managing Principal

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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1245.217

Identifier Type: -

Identifier Source: org_study_id

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