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RECRUITINGNA

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

NCT07187479•Well Cell Global

View on ClinicalTrials.gov

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)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Exclusion Criteria

•Has in the past two (2) years received treatment for a malignancy.
•Current pregnancy or intends to become pregnant during the study
•Has in the past one (1) year used non-prescription opioids or psychoactive drugs.
•Has in the past six (6) months had a hypoglycemic event requiring urgent care and/or administration of glucagon, osteocalcin, or parenteral glucose, unless approved for enrollment by the Medical Monitor.
•Has within the past one (1) month participated in a clinical study involving either of the following:
•* An investigational drug or procedure for any clinical indication
•* An investigation method for glucose control using approved agents
•Is nursing or is planning to nurse during the study.
•Has at screening a positive test for HIV (4th gen. screen), HBsAg, or HCV viral load.
•Has at screening, one or more of the following abnormal lab results:
+8 more criteria

Locations (1)

Arizona Kidney Disease and Hypertension Center

Phoenix, Arizona, United States

Key Dates

Start Date

October 14, 2025

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2026

Last Updated

October 20, 2025

Enrollment

120

ESTIMATED participants

Conditions

Chronic Kidney Disease (Stages 4 and 5)Kidney DiseaseType 2 Diabetes

Interventions

Physiologic Insulin Resensitization (PIR)

OTHER

Contacts

Richard Marchase, PhD

CONTACT

205-612-4763 rmarchase@gmail.com

Samantha Villaverde

CONTACT

904-806-8280 samantha@wellcellglobal.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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