Early Goal-Directed Care for Adults With Type 2 Diabetes and Kidney Disease
Tests early goal-directed care versus usual care in adults with diabetic kidney disease.
Plain-language title generated from the registry record
Registry title: Goal-Directed Therapy to Reduce Kidney and Cardiovascular Risk in Diabetic Kidney Disease (GOLD-STANDARD)
Key facts
- Where
- Toronto, CanadaSee the site
Where in Canada
- Sunnybrook Health Sciences CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sunnybrook Health Sciences Centre
- Trial code
- NCT07434791
- Record updated
- 4 September 2026
- Original description
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.Read full original descriptionShow less
GOaL Directed-STrategic Approach With New Disease-modifying theraApies to Reduce Kidney and Cardiovascular Risk in Patients With Diabetic Kidney Disease
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.
Inclusion: 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.
Exclusion: 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; Type 1 diabetes; Intolerance or allergy to any of RASi, SGLT2i, nsMRA or GLP1RA; HbA1c ≥10% within past 12 months; Serum potassium ≥ 5.2 mmol/L on screening labs; Known Heart Failure with Reduced Ejection Fraction (HFrEF); Baseline Blood Pressure (BP) < 100/60 mmHg at screening; Current pregnancy, lactation or women of childbearing potential, unless using highly effective contraception.