GOLD-STANDARD is a pragmatic, open-label pilot randomized controlled trial evaluating the feasibility and safety of early goal-directed Cardio-Kidney-Metabolic (CKM) care compared with usual care in patients with diabetic kidney disease. Participants will be randomized 1:1 and managed by nephrologists. The intervention includes structured kidney and cardiovascular risk assessment, early shared decision-making regarding guideline-directed medical therapies, and close monitoring for adverse effects. The usual care group will receive standard clinical management at the discretion of the treating clinician. The study will be conducted in Ontario using existing health care infrastructure.
GOLD-STANDARD is a parallel-group pilot randomized controlled trial designed to test early goal-directed CKM care in a real-world clinical setting. Participants will be randomized equally to the intervention or usual care arms. Intervention Arm: * Provides iterative assessment of kidney and cardiovascular risk to guide treatment decisions. * Implements early shared decision-making regarding initiation of guideline-directed medical therapies, following a structured 6-month protocol. The goal is to ensure each participant is offered timely treatment, though not all medications are expected to be initiated in every participant. * Supports close monitoring of side effects and treatment tolerance through multidisciplinary kidney care teams. Usual Care Arm: * Participants receive treatment according to standard clinical practice, with medication decisions made by the treating clinician. * Adjustments are incremental, guided by routine clinic visits and relevant biomarkers. * The trial is conducted within Ontario's health care infrastructure to evaluate the feasibility of early CKM care implementation across different clinical settings.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
The participants in the intervention arm will be referred to a Nephrologist and receive: 1. Iterative assessment of kidney and CV risk; 2. Early shared decision making regarding starting RASi, SGLT2i, nsMRA and GLP1RA, to reduce kidney and cardiovascular risk in diabetic kidney disease (DKD). This will be informed by a 6-month GDMT protocol and supported by multidisciplinary teams and/or health care technology 3. Close monitoring of side effects.
The standard care group will be prescribed medications based on clinical judgment by the clinician as usual care. Usual care involves incremental addition of treatment based on clinical judgment or specialty specific biomarkers (e.g. UACR) at clinic visits often spaced 3-12 months apart.
Feasibility of the pivotal Randomized Controlled Trial (RCT)
Percentage of consenting participants who are eligible and randomized. Feasibility is defined as ≥40% of consented and screened participants meeting criteria and being randomized.
Time frame: From consent through completion of screening procedures to randomization (maximum 60 days).
Prescription and Adherence to Guideline-Directed Medical Therapy (GDMT)
Determined based on the percentage of people prescribed and adherent to GDMT at 12 months when assessed on an ordinal scale from 1 to 4 medications.
Time frame: 12 months after randomization (±45-day window).
Declined/ Unable to Receive Treatment - RASi
Percentage of participants in the intervention group who were recommended a RASi prescription and did not receive treatment for any reason. Participants meeting any of the following criteria are counted toward this single percentage: * Declined due to patient preference * Unable to obtain due to access barriers * Not initiated or titrated to avoid anticipated side effects Unit of Measure: Percent (%)
Time frame: Baseline to 12 months post-randomization (±45-day visit window).
Declined or Unable to Receive Treatment- SGLT2i
Percentage of participants in the intervention group who were recommended a SGLT2i prescription and did not receive treatment for any reason. Participants meeting any of the following criteria are counted toward this single percentage: * Declined due to patient preference * Unable to obtain due to access barriers * Not initiated or titrated to avoid anticipated side effects Unit of Measure: Percent (%)
Time frame: Baseline to 12 months post-randomization (±45-day visit window).
Declined or Unable to Receive Treatment - nsMRA
Percentage of participants in the intervention group who were recommended an nsMRA prescription and did not receive treatment for any reason. Participants meeting any of the following criteria are counted toward this single percentage: * Declined due to patient preference * Unable to obtain due to access barriers * Not initiated or titrated to avoid anticipated side effects Unit of Measure: Percent (%)
Time frame: Baseline to 12 months post-randomization (±45-day visit window).
Declined or Unable to Receive Treatment - GLP1RA
Percentage of participants in the intervention group who were recommended an GLP1RA prescription and did not receive treatment for any reason. Participants meeting any of the following criteria are counted toward this single percentage: * Declined due to patient preference * Unable to obtain due to access barriers * Not initiated or titrated to avoid anticipated side effects Unit of Measure: Percent (%)
Time frame: Baseline to 12 months post-randomization (±45-day visit window).
Loss to follow-up
Percentage of participants who are lost to follow-up from baseline through 12 months post-randomization. The target for loss to follow-up is \<10% over the duration of the study. Unit of Measure: Percent (%)
Time frame: Baseline to 12 months post-randomization (±45-day visit window).
BMI
Change in body mass index (BMI) from baseline to 12 months. Calculated as 12-month value minus baseline value. Unit of Measure: kg/m²
Time frame: Baseline and 12 months post-randomization (±45-day visit window)
Waist circumference
Change in waist circumference from baseline to 12 months. Calculated as 12-month value minus baseline value. Unit of Measure: cm
Time frame: Baseline and 12 months post-randomization (±45-day visit window)
Hip circumference
Change in hip circumference from baseline to 12 months. Calculated as 12-month value minus baseline value. Unit of Measure: cm
Time frame: Baseline and 12 months post-randomization (±45-day visit window)
Waist-to-hip ratio
Change in waist-to-hip ratio from baseline to 12 months. Calculated as 12-month value minus baseline value. Unit of Measure: Ratio (unitless)
Time frame: Baseline and 12 months post-randomization (±45-day visit window)
Blood pressure
Change in systolic and diastolic blood pressure from baseline to 12 months. Calculated as 12-month value minus baseline value. Unit of Measure: mmHg
Time frame: Baseline and 12 months post-randomization (±45-day visit window)
Change in Urine Albumin-to-Creatinine Ratio (UACR)
Change in UACR from baseline to 12 months. Change will be calculated as 12-month value minus baseline value. Unit of Measure: mg/g
Time frame: Baseline and 12 months post-randomization (±45-day visit window)
Change in Estimated Glomerular Filtration Rate (eGFR)
Change in eGFR from baseline to 12 months. Change will be calculated as the 12-month value minus the baseline value.
Time frame: 12 months post-randomization (visit window ±45 days).
All-cause mortality
Death from any cause occurring from baseline to 12 months post-randomization. Unit of Measure: Number of participants
Time frame: Baseline to 12 months post-randomization (±45-day visit window)
Hospitalization for myocardial infarction
Any hospitalization for myocardial infarction occurring from baseline to 12 months post-randomization. Both incident and recurrent events will be captured. Unit of Measure: Number of participants
Time frame: Baseline to 12 months post-randomization (±45-day visit window)
Hospitalization for stroke
Any hospitalization for stroke occurring from baseline to 12 months post-randomization. Both incident and recurrent events will be captured. Unit of Measure: Number of participants
Time frame: Baseline to 12 months post-randomization (±45-day visit window)
Hospitalization for heart failure
Any hospitalization for heart failure occurring from baseline to 12 months post-randomization. Both incident and recurrent events will be captured. Unit of Measure: Number of participants
Time frame: Baseline to 12 months post-randomization (±45-day visit window)
All-cause hospitalization
Any hospitalization for any cause occurring from randomization to 12 months post-randomization. Ascertainment via Connecting Ontario administrative health data. Unit of Measure: Number of participants
Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)
Hospitalization for diabetic ketoacidosis (DKA)
Any hospitalization for DKA occurring from randomization to 12 months post-randomization. Ascertainment via Connecting Ontario administrative health data. Unit of Measure: Number of participants
Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)
Hyperkalemia requiring medication discontinuation or dose reduction
Occurrence of hyperkalemia leading to discontinuation or dose reduction of study medications (RASi, SGLT2i, nsMRA, GLP1RA) from randomization to 12 months post-randomization. Ascertainment via review of clinic notes and medication records. Unit of Measure: Number of participants
Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)
eGFR dip requiring medication discontinuation or dose reduction
Occurrence of an eGFR decline requiring discontinuation or dose reduction of study medications from randomization to 12 months post-randomization. Ascertainment via review of clinic notes and medication records. Unit of Measure: Number of participants
Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)
Symptomatic hypotension requiring medication discontinuation or dose reduction
Occurrence of symptomatic hypotension (SBP \<90 mmHg) leading to discontinuation or dose reduction of study medications from randomization to 12 months post-randomization. Ascertainment via review of clinic notes and medication records. Unit of Measure: Number of participants
Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)
All-cause medication discontinuation
Discontinuation of any study medication for any reason from randomization to 12 months post-randomization. Ascertainment via review of clinic notes and medication records. Unit of Measure: Number of participants
Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)
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