Goal-Directed Heart, Kidney, and Metabolic Care to Help Adults with Diabetic Kidney Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pragmatic, open-label pilot randomized trial compares an early goal-directed Cardio-Kidney-Metabolic (CKM) care strategy to usual care in adults with type 2 diabetes and diabetic kidney disease. Participants are followed for 12 months to measure how well the CKM approach can be implemented, including recruitment, adherence, retention, and safety. The study aims to inform the design of a larger future trial and to assess whether integrated CKM management can be safely adopted within routine nephrology practice in Ontario. Primary focus is on feasibility and safety, with secondary data on treatment uptake and potential signals of benefit.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Age ≥ 18 years
2. T2DM
3. CKD (eGFR ≥ 25-60 mL/min/1.73 m² OR UACR ≥ 30 mg/g) - on screening labs
4. High Cardiovascular (CV) Risk: Defined as a history of prior myocardial infarction (MI), stroke, or peripheral artery disease (PAD), or the presence of cardiovascular risk factors, (specifically age 40 years or older and at least one of the following: cholesterol above target (LDL≥1.8 mmol/L OR on cholesterol lowering medication - within past 24 months), hypertension (≥130/80 mmHg or on BPLMs), or atrial fibrillation.)
5. Open to start new medications

Exclusion Criteria:

1. Type 1 diabetes
2. HbA1c ≥10% within past 12 months
3. Serum potassium ≥ 5.2 mmol/L on screening labs
4. Baseline Blood Pressure (BP) \< 100/60 mmHg at screening
5. Treated with new or intensified immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days
6. Kidney Transplant
7. In the opinion of the investigator, currently treated with maximum tolerated dose of ≥3 medication classes:: RASi, SGLT2i, nsMRA or GLP1RA
8. Currently prescribed all 4 medication classes : RASi, SGLT2i, nsMRA or GLP1RA
9. Intolerance or allergy to any of RASi, SGLT2i, nsMRA or GLP1RA
10. Known Heart Failure with Reduced Ejection Fraction (HFrEF)
11. Current pregnancy, lactation or women of childbearing potential, unless using highly effective contraception

Where it's running

• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Ayodele Odutayo, Doctor
• Email: ayodele.odutayo@sunnybrook.ca
• Phone: 416-480-6100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.