Goal-Directed Therapy to Reduce Kidney and Cardiovascular Risk in Diabetic Kidney Disease (GOLD-STANDARD)
Recruiting now NCT07434791
Run by Sunnybrook Health Sciences Centre · for 18 and older · All sexes
What this study is about
GOLD-STANDARD is a pragmatic, open-label pilot randomized controlled trial evaluating the feasibility, safety, and implementation of an early goal-directed Cardio-Kidney-Metabolic (CKM) care strategy compared with usual care in adults with type 2 diabetes and diabetic kidney disease who are at increased cardiovascular risk. Participants will be followed for 12 months to assess treatment uptake, adherence, retention, and safety outcomes, and to inform the design of a future definitive trial.
Who can join (things the study team will check)
✅ You may be able to join if…
- Age ≥ 18 years
- T2DM
- CKD (eGFR ≥ 25-60 mL/min/1.73 m² OR UACR ≥ 30 mg/g) - on screening labs
- 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.)
- Open to start new medications
🚫 You may not be able to join if…
- Type 1 diabetes
- HbA1c ≥10% within past 12 months
- Serum potassium ≥ 5.2 mmol/L on screening labs
- Baseline Blood Pressure (BP) < 100/60 mmHg at screening
- Treated with new or intensified immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days
- Kidney Transplant
- In the opinion of the investigator, currently treated with maximum tolerated dose of ≥3 medication classes:: RASi, SGLT2i, nsMRA or GLP1RA
- Currently prescribed all 4 medication classes : RASi, SGLT2i, nsMRA or GLP1RA
- Intolerance or allergy to any of RASi, SGLT2i, nsMRA or GLP1RA
- Known Heart Failure with Reduced Ejection Fraction (HFrEF)
- Current pregnancy, lactation or women of childbearing potential, unless using highly effective contraception
Where this trial is running
- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Who to contact
Ayodele Odutayo, Doctor · 416-480-6100 · ayodele.odutayo@sunnybrook.ca
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07434791.
Verify everything on the official ClinicalTrials.gov record. Page updated September 2026.