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Completed

NCT Number: NCT04445181

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

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.

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Key information

Conditions

Chronic Kidney Disease in Type 2 Diabetes

Sex eligibility

All sexes

Study type

Observational

Primary location

A Database

A Database, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Among patients who meet the inclusion criteria, estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73 m^2 and/or urine albumin-to-creatinine ratio (uACR) ≥ 2 mg/mmol will be used to identify the cohort of patients with T2D and CKD

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

Treatment and study plan

The physician's prescription in routine clinical practice

Drug

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

Primary outcomes

  1. Proportion of patients with CKD in a large T2D population

    Time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019

    The data will be retrieved from the LMC Diabetes Registry, a Pan-Canadian registry of diabetes community-based specialist practices and used to develop a renal registry to investigate the primary objectives of the study

Secondary outcomes

  1. Proportion of patients using the different therapies

    Time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019

    The therapies are: ACEi, ARBs, ACEi/ARBs, MRAs, GLP-1 RA and SGLT2i

  2. Proportion of patients with stage 1 CKD with moderate or greater albuminuria, stage 2 CKD with moderate or greater albuminuria, stage 3a CKD, stage 3b CKD, stage 4 CKD and stage 5 CKD in accordance with Canadian clinical practice guidelines

    Time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019

    Stage 1 CKD: eGFR (estimated glomerular filtration rate) ≥ 90 ml/min/1.73 m^2 Stage 2 CKD: eGFR between 60-89 ml/min/1.73 m^2 Stage 3a CKD: eGFR between 45-59 ml/min/1.73 m^2 Stage 3b CKD: eGFR between 30-44 ml/min/1.73 m^2 Stage 4 CKD: eGFR between 15-29 ml/min/1.73 m^2 Stage 5 CKD: eGFR <15 ml/min/1.73 m^2

  3. Proportion of patients with microalbuminuria and macroalbuminuria, in accordance with Canadian clinical practice guidelines

    Time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019

    Microalbuminuria: uACR (urine albumin-to-creatinine ratio) 2-20 mg/mmol Macroalbuminuria: uACR > 20 mg/mmol

  4. Proportion of patients within each albuminuria category (A1, A2 or A3), in accordance with KDIGO clinical practice guidelines

    Time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019

    KDIGO = Kidney Disease: Improving Global Outcomes

  5. Laboratory values for patients using either no therapy or using a therapy for ≥ 6 months

    Time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019

    Laboratory values including glucose, glycated hemoglobin (HbA1c), lipids, creatinine, electrolytes, eGFR, and uACR

  6. Proportion of patients with different comorbidities

    Time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019

    Comorbidities like hypertension, dyslipidemia, microvascular disease, macrovascular disease

  7. Proportion of healthcare provider prescriptions of RAS therapies (ACEi/ARB) used to treat hypertension, heart failure, coronary artery disease, CKD, or other condition

    Time frame: On the day of healthcare provider completes a questionnaire

    RAS: renin angiotensin system ACEi: angiotensin converting enzyme inhibitors ARB: angiotensin receptor blocker

    Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D

  8. Proportion of healthcare provider prescriptions of GLP-1 RA used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition

    Time frame: On the day of healthcare provider completes a questionnaire

    GLP-1 RA: glucagon-like peptide-1 receptor agonist

    Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D

  9. Proportion of healthcare provider prescriptions of MRAs used to treat hypertension, heart failure, coronary artery disease, CKD or other condition

    Time frame: On the day of healthcare provider completes a questionnaire

    MRAs: mineralocorticoid receptor antagonists

    Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D

  10. Proportion of healthcare provider prescriptions of SGLT2i used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition

    Time frame: On the day of healthcare provider completes a questionnaire

    SGLT2i: sodium-glucose co-transporter-2 inhibitors

    Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Canadian REgistry of Chronic Kidney Disease in Diabetes Outcomes (CREDO) Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2020
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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