Randomized, Open Label Study to Examine the Outcomes of Physiologic Insulin Resensitization in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
Well Cell Global
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).
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)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Is age 18 or older (male or female) * Have a documented diagnosis of CKD stage 3b, 4, or 5 and T2DM of 6 months or greater prior to screening. Patients may have treatment regimens associated with T2DM that include diabetic oral and/or injectable medications including insulin and/or GLP-1 receptor agonists. * In the opinion of the Investigator, has been on an appropriate, stable regimen for management of any complications present for the past six (6) months. * In the opinion of the Investigator, is able to do all of the following: * Provide valid informed consent. *…
Interventions
- OtherPhysiologic Insulin Resensitization (PIR)
PIR is a physician-directed treatment that uses an exterior infusion pump to deliver insulin intravenously.
Location
- Arizona Kidney Disease and Hypertension CenterPhoenix, Arizona