By InvitationPhase 4

Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study

Denmark50 participantsStarted 2025-11-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Men and women over 18 years of age.
✓. Type 2 diabetes with no clinical signs of HF NYHA Class IV
✓. Able to understand the written participant information and give informed consent.

Exclusion criteria

✕. Heart failure NYHA class IV at screening
✕. Moderately - or severely increased albuminuria with a UACR ≥ 200 mg/g or CKD with an eGFR \< 30 ml/min/1.73m2 at the screening visit.
✕. A female who is pregnant, breastfeeding, or intends to become pregnant, or women of childbearing potential (WOCBP) who are not using highly effective contraceptive methods.
✕. Receiving therapy with all three of the study medication prior to enrolment.
✕. Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrolment
✕. Known or suspected hypersensitivity to the study medications or related products
✕. History of pancreatitis at the screening visit
✕. Body mass index \< 18.5 kg/m2 at the screening visit

What they're measuring

Proteomic feasibility

Timeframe: 2 weeks from sampling

Evaluation of medical treatment

Timeframe: 3 weeks from sampling

Trial details

NCT IDNCT06954090

SponsorSteno Diabetes Center Copenhagen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

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