Actively Recruiting
Impact of New Anti-glycemic Drugs and Immunosuppressive Therapies on NETosis in Diabetes and Immune-Mediated Kidney Disease
Led by Western Galilee Hospital-Nahariya · Updated on 2025-02-12
70
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether new glucose-lowering medications like SGLT2 inhibitors (e.g., Forxiga/Jardiance) and GLP-1 receptor agonists (e.g., Ozempic) can reduce a process called NETosis in people with diabetes. NETosis involves the release of substances by certain white blood cells that can cause inflammation and damage, contributing to problems like heart disease and kidney damage. The study also looks at how immunosuppressive treatments affect NETosis in patients with immune-related kidney diseases such as ANCA-associated vasculitis. The study includes diabetic patients starting treatment with either SGLT2 inhibitors or GLP-1 receptor agonists, and chronic kidney disease (CKD) patients receiving immunosuppressive therapy for immune-mediated kidney conditions. Blood samples will be collected before treatment and at 1, 2, 3, 6, and 12 months after starting therapy to measure markers of NETosis. A control group of healthy participants will also provide samples for comparison. Participants will provide blood samples at multiple time points throughout the year to monitor changes in NETosis markers such as citrullinated histone H3, myeloperoxidase, neutrophil elastase, and PAD4. Kidney function, urine protein levels, cardiovascular events, and overall mortality will also be tracked during treatment and for up to five years. This comprehensive approach aims to understand how these treatments influence inflammation and disease progression in diabetes and kidney disease.
CONDITIONS
Brief Title
Impact of Antiglycemic & Immunosuppressive Therapies on NETosis in Diabetes & Kidney Disease (NETs - Neutrophil Traps)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diabetic patients aged 18 years or older (men and women).
- Patients who have not previously received SGLT2 inhibitors or GLP-1 receptor agonists.
- Chronic kidney disease patients with various causes.
- Focus on immune-mediated kidney disease, such as ANCA-associated vasculitis, for the CKD group.
You will not qualify if you...
- Patients with acute infections.
- Patients with hematologic or oncologic diseases.
- Patients positive for HIV.
- Patients positive for Hepatitis B or C.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants have blood samples collected to measure NETosis markers and other clinical variables before starting treatment and during the first year of therapy.
6 visits at baseline, 1, 2, 3, 6, and 12 months
Duration - Up to 5 years
Participants are monitored annually for up to 5 years to assess kidney function, cardiovascular events, and overall health after treatment initiation.
Annual visits after the first year, up to 5 years
Trial Site Locations
Total: 1 location
1
Galilee Medical Center
Nahariya, Israel, 2210001
Actively Recruiting
Research Team
E
Etty Kruzel-Davila, MD
O
Olga Vdovich, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here