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RecruitingNCT07187479

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

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Trial Parameters

ConditionChronic Kidney Disease (Stages 4 and 5)
SponsorWell Cell Global
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment120
SexALL
Min Age18 Years
Max AgeN/A
Start Date2025-10-14
Completion2026-06
Interventions
Physiologic Insulin Resensitization (PIR)

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Brief 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).

Eligibility Criteria

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. * Understand and comply with study procedures as presented in the consent process. * Has the capacity or support to attend all required visits. * If female, the subject must meet either of the following sets of conditions: o Is of non-childbearing potential, defined as meeting either of the following criteria: * Age ≥50 years and post-menopausal for at least one (1) year * Surgically sterile due to bilate

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