A Study Using the LMC Diabetes Registry to Learn More About Chronic Kidney Disease (CKD) in Canadian Patients With Type 2 Diabetes (T2D)

NCT ID: NCT04445181

Last Updated: 2021-10-05

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

14873 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-11-23

Brief Summary

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In people with type 2 diabetes (T2D), the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels.

People with T2D are at a higher risk of having a condition called chronic kidney disease (CKD). In people with CKD, the kidneys become damaged and do not work as they should. People with CKD can have trouble breathing and often have swelling in their arms and legs, and high blood pressure.

People who have CKD and T2D are more likely to have other medical problems, such as heart disease.

There are many treatments available to patients who have CKD and T2D. But, researchers need more information about how doctors in Canada are deciding which treatment to give these patients.

In this study, the researchers will review health information from men and women with T2D who visited a doctor in 2019 and had check-ups for at least 6 months. The health information will be taken from a Canadian registry (or database) owned by LMC Diabetes \& Endocrinology. The registry contains information from people that went to an LMC clinic. In this study, the researchers will learn how many of these people had T2D and CKD. They will learn the treatments these people received, and if they had other related medical problems. The researchers will also use surveys to ask the doctors about why they chose certain treatments.

Detailed Description

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Conditions

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Chronic Kidney Disease in Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with T2D

Active patients (defined as patients seen by an LMC endocrinologist between January 1, 2019 and December 31, 2019) with T2D (Type 2 Diabetes). Among the patients with T2D, those identified with CKD will be included in the renal registry.

The physician's prescription in routine clinical practice

Intervention Type DRUG

This is an Observational study that will not involve prescription of the drugs.

Healthcare providers

Healthcare providers caring for patients with CKD and T2D.

No interventions assigned to this group

Interventions

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The physician's prescription in routine clinical practice

This is an Observational study that will not involve prescription of the drugs.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of T2D as captured in the LMC EMR system
* Assessed by an LMC endocrinologist between January 1, 2019 and December 31, 2019
* Followed by an LMC endocrinologist for ≥ 6 months prior to inclusion in the cohort
* Informed consent to use patient medical record data for research purposes was provided

Exclusion Criteria

\- Any patients with documented non-diabetic etiology for renal disease will be excluded from the numerator (number of patients with CKD and T2D) when determining the primary endpoint
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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A Database

A Database, , Canada

Site Status

Countries

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Canada

References

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Chu L, Fuller M, Jervis K, Ciaccia A, Abitbol A. Prevalence of Chronic Kidney Disease in Type 2 Diabetes: The Canadian REgistry of Chronic Kidney Disease in Diabetes Outcomes (CREDO) Study. Clin Ther. 2021 Sep;43(9):1558-1573. doi: 10.1016/j.clinthera.2021.07.015. Epub 2021 Aug 21.

Reference Type DERIVED
PMID: 34426012 (View on PubMed)

Related Links

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http://clinicaltrials.bayer.com/

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Other Identifiers

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21190

Identifier Type: -

Identifier Source: org_study_id

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