Systemic Albumin Leakage as proxy for Vascular inflAmmaTion and cardiovascular disease in diabEtes patients; the SALVATE study

• Conditions: Cardiovascular disease; diabetes mellitus type 2; 10038430; 10047066

• Registration Number: NL-OMON56987
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

• Men and women, age >= 18 years.
• Written informed consent.
• eGFR above 60 ml/min/1,73m2.
• Using renin-angiotensin system (RAS) inhibitors.
• Fulfils ADA criteria for diabetes.
o Fasting plasma glucose >= 7.0 mmol/l.
o Random plasma glucose >= 11.1 mmol/l.
o HbA1C >= 6,5%.

Exclusion Criteria

• Patients who are mentally incompetent and cannot sign a Patient Informed
Consent or are unwilling to sign a Patient Informed Consent.
• Women who are currently pregnant, planning to become pregnant, breastfeeding
women, or women with childbearing potential not using appropriate contraceptive
measures. This will be discussed during the intake conversation and women who
answer yes on any of the previous questions will be excluded.
• Other causes for macroalbuminuria than nephropathy.
• Systemic auto-immune disease or vasculitis.
• Inflammation of unknown origin or sepsis.
• Patients who use immunosuppressives or anti-inflammatory drugs that could
interfere with the study results.
• Recent (< 3 months) acute disease such as cardiovascular event or infection
for which admission to hospital was necessary.
• Recent (< 3 months) surgical procedure, excluding procures under local
anaesthetics.
• Active malignancy, excluding skin malignancies: basal cell carcinoma and
squamous cell carcinoma,
• Patients who have claustrophobia.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified