Study of Physiologic Insulin Resensitization Treatment in Adults With Chronic Kidney Disease and Type 2 Diabetes

What this Trial Is About

Researchers are evaluating the outcomes of Physiologic Insulin Resensitization PIR treatment compared to standard care in patients with chronic kidney disease CKD stages 3b, 4, or 5 and type 2 diabetes mellitus T2DM. This study focuses on how PIR affects kidney function and diabetes management in these patients. The trial is randomized and open-label, sponsored by Well Cell Global, aiming to assess treatment impact on this specific patient population. Participants are assigned to one of two groups one receiving PIR, a treatment delivered through an external infusion pump that provides insulin intravenously under physician direction, and the other receiving standard care without additional intervention. The study evaluates these treatments in parallel, monitoring effects over a period of at least 24 weeks. During the study, participants undergo assessments of kidney function, including estimated glomerular filtration rate eGFR, blood urea nitrogencreatinine ratio, cystatin C, and urine albumin-creatinine ratio at 12 and 24 weeks. Secondary measures include diabetes control markers such as hemoglobin A1c, fasting glucose, fasting insulin, and quality of life questionnaires. Researchers also monitor medication usage, blood pressure, lipid profiles, and other lab tests to understand treatment effects. The total participation time extends through the 24-week evaluation period with ongoing safety and outcome monitoring.

Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus