Physiologic Insulin Resensitization for Chronic Kidney Disease and Type 2 Diabetes

Overseen By Samantha Villaverde

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Well Cell Global

Must not be taking: Non-prescription opioids, Psychoactive drugs

Disqualifiers: Malignancy, Pregnancy, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Physiologic Insulin Resensitization (PIR) for individuals with both Chronic Kidney Disease (CKD) and Type 2 Diabetes (T2DM). The goal is to assess how well PIR helps these patients manage their conditions compared to standard care. The trial includes two groups: one will receive PIR, and the other will continue with their usual care. Suitable candidates have CKD stage 3b, 4, or 5 and T2DM for at least six months and follow a stable treatment plan for any complications.

As an unphased trial, this study allows patients to contribute to groundbreaking research that could enhance future treatment options.

Do I need to stop my current medications to join the trial?

The trial does not specify that you need to stop your current medications. It mentions that participants can be on a stable regimen for managing their conditions, including diabetes medications like insulin and GLP-1 receptor agonists.

What prior data suggests that Physiologic Insulin Resensitization (PIR) is safe for patients with Chronic Kidney Disease and Type 2 Diabetes?

Researchers are investigating a treatment called Physiologic Insulin Resensitization (PIR) for individuals with Chronic Kidney Disease (CKD) and Type 2 Diabetes. Currently, clear information about its safety is limited. The study remains in the early stages, so detailed safety data might not yet be available.

PIR reintroduces insulin to the body in a way that aims to enhance its effectiveness. This method is still under study, and no serious side effects have been widely reported. While it shows promise, potential participants should consult their doctor about the possible risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about Physiologic Insulin Resensitization (PIR) for treating chronic kidney disease and type 2 diabetes because it offers a fresh approach compared to standard treatments like metformin or insulin injections. Unlike these traditional treatments, which primarily focus on managing blood sugar levels, PIR aims to improve the body's own response to insulin, potentially addressing the root cause of insulin resistance. This method could lead to better long-term outcomes by enhancing the body's natural ability to use insulin effectively, which is a novel strategy in managing these conditions.

What evidence suggests that Physiologic Insulin Resensitization might be an effective treatment for Chronic Kidney Disease and Type 2 Diabetes?

Research has shown that Physiologic Insulin Resensitization (PIR), which participants in this trial may receive, could benefit people with Chronic Kidney Disease (CKD) and Type 2 Diabetes (T2DM). In one study, 91% of patients either improved or maintained their condition when treated with PIR. This finding suggests that PIR might effectively manage symptoms of CKD and T2DM. Additionally, PIR has been associated with lower treatment costs, potentially making it a more affordable option for managing these conditions. While more research is needed, early results indicate that PIR is an effective option for people with CKD and T2DM. ^{1 2 3 4 6}

Who Is on the Research Team?

Sungchun Lee, MD

Principal Investigator

Arizona Kidney Disease and Hypertension Centers

Are You a Good Fit for This Trial?

This trial is for adults with both Chronic Kidney Disease (stages 3b, 4, or 5) and Type 2 Diabetes Mellitus. They should have stable health conditions for the past six months and agree to use birth control if of childbearing potential. Exclusions include recent severe hypoglycemia, other clinical study participation within a month, certain infections like HIV/HBV/HCV, abnormal lab results, psychiatric issues affecting compliance, recent cancer treatment or drug abuse.

Inclusion Criteria

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

If female, the subject must meet either of the following sets of conditions: 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 bilateral tubal ligation, bilateral oophorectomy, or hysterectomy, Is of childbearing potential and meets both of the following criteria: Has a negative serum pregnancy test (beta-human chorionic gonadotropin) at screening, Agrees to practice an acceptable method of birth control (contraception) from screening until at least 30 days after last study treatment

I am 18 years old or older.

Exclusion Criteria

Current pregnancy or intends to become pregnant during the study

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Physiologic Insulin Resensitization (PIR) or Standard of Care (SOC) treatment

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physiologic Insulin Resensitization (PIR)

Trial Overview The trial is testing Physiologic Insulin Resensitization (PIR) in patients who have both Chronic Kidney Disease and Type 2 Diabetes Mellitus. It aims to see how well PIR works in improving insulin sensitivity and overall diabetes management in this specific patient group.

How Is the Trial Designed?

Group I: Physiologic Insulin Resensitization (PIR) Group Experimental Treatment 1 Intervention

Subject to receive Physiologic Insulin Resensitization (PIR)

Group II: Standard of Care (SOC) Group Active Control 1 Intervention

Subjects will receive standard of care

Who Is Running the Clinical Trial?

Well Cell Global

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07187479?aggFilters=status%3A

Outcomes of Physiologic Insulin Resensitization (PIR) in ... 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 ...

2. ajmc.com ajmc.com/view/physiologic-insulin-resensitization-lowers-cost-in-patients-with-diabetes-and-kidney-disease

Physiologic Insulin Resensitization Lowers Cost in Patients ... Physiologic insulin resensitization (PIR) treatment resulted in lower treatment costs for patients with diabetes and chronic kidney disease (CKD) ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39847789/

Physiologic insulin resensitization lowers cost in patients ... Conclusions: PIR is a possible method of reducing the cost of treating patients with diabetes and CKD. Given the rapidly increasing numbers of ...

4. biomedgrid.com biomedgrid.com/pdf/AJBSR.MS.ID.003434.pdf

Chronic Kidney Disease Recovery Utilizing Physician- ... Overall, while more research is needed to fully understand its long-term benefits, we demonstrate in 66 patients, 91% improve or remain stable ...

5. ctdiabetescenter.com ctdiabetescenter.com/wp-content/uploads/2024/12/New-CKD-Study-2024.pdf

Physician-Directed Physiologic Insulin Resensitization The prevalence of pre-diabetes suggests a high likelihood of future increased dialysis and/or kidney transplantation along with significant ...

6. diamedics.com diamedics.com/wp-content/uploads/2025/04/Lakey-Efficacy-of-Physiologic-Insulin-Resensitization-as-a-Treatment-for-Insulin-Resistance-Pathophysiology_05.09.24-1.pdf

Lakey-Efficacy-of-Physiologic-Insulin-Resensitization-as-a- ... Physiologic Insulin Resensitization shows potential for improvement in diabetic nephropathy. Avoidance of nephropathy and Diabetic Kidney Disease progression ...