Evaluating the Effect of Hemodialysis Modality and New Anti-glycemic Drugs on NETosis on in Hemodialysis and Diabetic Patient, and Assessment of NETosis in Various Kidney Diseases

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This study aims to investigate whether new glucose-lowering medications, such as SGLT2 inhibitors (e.g., Forxiga/Jardiance) and GLP-1 receptor agonists (e.g., Ozempic), can reduce NETosis in diabetic patients, thereby mitigating secondary complications such as cardiovascular disease and kidney damage. By targeting dysregulated NET formation, the study seeks to establish a link between reduced NETosis and improved clinical outcomes in diabetes. Additionally, the study will evaluate the effects of immunosuppressive therapies on NETosis in patients with immune-mediated kidney diseases, such as ANCA-associated vasculitis. By correlating NETosis activity with disease progression and treatment response, this research will assess whether reducing NETosis contributes to better management of inflammation and secondary morbidity in these conditions. Through these evaluations, the study aims to identify potential therapeutic strategies to improve outcomes in both diabetic and chronic kidney disease populations.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

‣ DM therapy study: - 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 (CKD) patients :50 CKD patients with various etiologies.

• • Focus:

• This part of the study will specifically evaluate immune-mediated kidney disease, such as ANCA-associated vasculitis, and the effects of immunosuppressive therapy on NETosis.

Locations
Other Locations
Israel
Galilee Medical Center
RECRUITING
Nahariya
Contact Information
Primary
Etty Kruzel-Davila, MD
ETTYK@gmc.gov.il
972-4-9107619
Backup
Olga Vdovich, MD
olgav@gmc.gov.il
Time Frame
Start Date: 2024-05-13
Estimated Completion Date: 2031-12-30
Participants
Target number of participants: 70
Treatments
Diabetes mellitus patients
2\. Diabetic Patients (DM Therapy Study)~* Sample Size: 20 diabetic patients.~ * Group 1: 10 patients treated with Forxiga/Jardiance (SGLT2 inhibitors).~ * Group 2: 10 patients treated with Ozempic (GLP-1 agonist).~* Patient Criteria:~ o Patients naïve to SGLT2 inhibitors and GLP-1 receptor agonists to ensure the observed effects are attributable to the initiation of these therapies.~* Sample Collection:~ * Serum samples (6 ml in serum separator tubes).~ * Two tubes (12 ml total) will be collected per participant at each time point:~Before starting treatment and at 1, 2, 3, 6, and 12 months after initiating medication.~* Inclusion Criteria:~ * Diabetic patients aged 18 years or older (men and women).~ * Patients who have not previously received SGLT2 inhibitors or GLP-1 receptor agonists.~* Exclusion Criteria:~ * Patients with conditions affecting NETosis, including autoimmunity, hematologic or oncologic diseases, or positive for HIV or Hepatitis B/C.
Chronic kidney disease (CKD) patients
Chronic Kidney Disease (CKD) Patients (Evaluation of Immunosuppressive Therapy)~* Sample Size: 50 CKD patients with various etiologies.~* Focus:~ o This part of the study will specifically evaluate immune-mediated kidney disease, such as ANCA-associated vasculitis, and the effects of immunosuppressive therapy on NETosis.~* Objective:~ * Assess NETosis markers (e.g., cfDNA, Cit-H3, MPO, NE) before initiating immunosuppressive treatment and at 1, 2, 3, 6, and 12 months of therapy.~ * Correlate NETosis dynamics with clinical variables, including disease activity, renal function, and inflammatory markers.~* Sample Collection:~ o Serum samples (6 ml in serum separator tubes).~ o Two tubes (12 ml total) will be collected per participant at each time point: Before starting treatment and at 1, 2, 3, 6, and 12 months after initiating medication.~* Exclusion Criteria:~ * Patients with acute infections, hematologic or oncologic diseases, or positive for HIV or Hepatitis B/C.
10 healthy participants will be recruited to the control group (for both studies).
Control Group~* Sample Size: 10 healthy participants.~* Objective:~ o Serve as controls for both the diabetic and CKD studies.~* Sample Collection:~* Two tubes (12 ml total) will be collected per participant~* Eligibility:~ * Healthy individuals without underlying medical conditions.
Related Therapeutic Areas
Sponsors
Leads: Western Galilee Hospital-Nahariya

This content was sourced from clinicaltrials.gov