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Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study
Sponsor: Steno Diabetes Center Copenhagen
Summary
Title: Body fluid proteome SIGnatures for persoNALised intervention to prevent cardiovascular and renal complications in diabetes. Aim: To explore the feasibility of using urinary proteomic risk scores in clinical practice to identify patients at risk of developing end organ damage and identify which patients should receive additional renocardiovascular protective treatment.
Official title: SIGNAL - Body Fluid Proteome SIGnatures for persoNALised Intervention to Prevent Cardiovascular and Renal Complications in Diabetes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-11-20
Completion Date
2027-05-31
Last Updated
2025-12-22
Healthy Volunteers
No
Interventions
Semaglutide, 1.34 mg/mL
Semaglutide will be introduced at a dose of 0.25 mg/week subcutaneous injection, escalated to 0.5 and 1.0 mg/week after 4 and 8 weeks if tolerated.
Finerenone Oral Tablet
Finerenone will be introduced at a dose of 10 mg/day in patients with a serum potassium level \< 4.8 mmol/l and eGFR \< 60 ml/min/1.73 m2 and escalated to 20 mg/day after 4 weeks if the serum potassium level is still \< 4.8 mmol/l. Starting dose is 20 mg/day if eGFR ≥ 60 ml/min/1.73 m2. The dosage will be reduced or discontinued in patients who develop hyperkalemia (serum potassium \> 5.5 mmol/l).
Dapagliflozin (DAPA)
Dapagliflozin will be introduced at a dose of 10 mg/day. The dose can be reduced at any time during the trial if required by the subject's tolerance to the product.
Locations (1)
Steno Diabetes Center Copenhagen
Herlev, Hajdú-Bihar, Denmark