check_circleStudy Completed
Chronic Kidney Disease in Type 2 Diabetes
Bayer Identifier:
21190
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A study using the LMC Diabetes Registry to learn more about chronic kidney disease (CKD) in Canadian patients with type 2 diabetes (T2D)
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
NaN - N/ATrial summary
Enrollment Goal
14873Trial Dates
July 2020 - November 2020Phase
N/ACould I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | a database | a database, Canada |
Primary Outcome
- Proportion of patients with CKD in a large T2D populationThe 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 studydate_rangeTime Frame:Retrospectively analysis between January 1, 2019 and December 31, 2019
Secondary Outcome
- Proportion of patients using the different therapiesThe therapies are: ACEi, ARBs, ACEi/ARBs, MRAs, GLP-1 RA and SGLT2idate_rangeTime Frame:Retrospectively analysis between January 1, 2019 and December 31, 2019
- 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 guidelinesStage 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^2date_rangeTime Frame:Retrospectively analysis between January 1, 2019 and December 31, 2019
- Proportion of patients with microalbuminuria and macroalbuminuria, in accordance with Canadian clinical practice guidelinesMicroalbuminuria: uACR (urine albumin-to-creatinine ratio) 2-20 mg/mmol Macroalbuminuria: uACR > 20 mg/mmoldate_rangeTime Frame:Retrospectively analysis between January 1, 2019 and December 31, 2019
- Proportion of patients within each albuminuria category (A1, A2 or A3), in accordance with KDIGO clinical practice guidelinesKDIGO = Kidney Disease: Improving Global Outcomesdate_rangeTime Frame:Retrospectively analysis between January 1, 2019 and December 31, 2019
- Laboratory values for patients using either no therapy or using a therapy for ≥ 6 monthsLaboratory values including glucose, glycated hemoglobin (HbA1c), lipids, creatinine, electrolytes, eGFR, and uACRdate_rangeTime Frame:Retrospectively analysis between January 1, 2019 and December 31, 2019
- Proportion of patients with different comorbiditiesComorbidities like hypertension, dyslipidemia, microvascular disease, macrovascular diseasedate_rangeTime Frame:Retrospectively analysis between January 1, 2019 and December 31, 2019
- Proportion of healthcare provider prescriptions of RAS therapies (ACEi/ARB) used to treat hypertension, heart failure, coronary artery disease, CKD, or other conditionRAS: 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 T2Ddate_rangeTime Frame:On the day of healthcare provider completes a questionnaire
- Proportion of healthcare provider prescriptions of GLP-1 RA used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other conditionGLP-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 T2Ddate_rangeTime Frame:On the day of healthcare provider completes a questionnaire
- Proportion of healthcare provider prescriptions of MRAs used to treat hypertension, heart failure, coronary artery disease, CKD or other conditionMRAs: mineralocorticoid receptor antagonists Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2Ddate_rangeTime Frame:On the day of healthcare provider completes a questionnaire
- Proportion of healthcare provider prescriptions of SGLT2i used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other conditionSGLT2i: sodium-glucose co-transporter-2 inhibitors Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2Ddate_rangeTime Frame:On the day of healthcare provider completes a questionnaire
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A