NCT07187479

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

Randomized, Open Label Study to Examine the Outcomes of Physiologic Insulin Resensitization in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Well Cell Global · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to evaluate outcomes of physiologic insulin re-sensitization (PIR) in patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM).

Detailed description

The primary objective of this study is to assess the outcomes of Physiologic Insulin Resensitization (PIR) treatment compared to standard of care (SOC) on renal patients with a diagnosis of chronic kidney disease (CKD) (stages 3b, 4 and 5) and Type 2 diabetes mellitus (T2DM)

Conditions

• Chronic Kidney Disease (Stages 4 and 5)
• Kidney Disease
• Type 2 Diabetes

Interventions

Type	Name	Description
OTHER	Physiologic Insulin Resensitization (PIR)	PIR is a physician-directed treatment that uses an exterior infusion pump to deliver insulin intravenously.

Timeline

• Start date: 2025-10-14
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-09-23
• Last updated: 2025-10-20

Locations

1 site across 1 country: United States