Back to search results

Physiologic Insulin Resensitization (PIR) for Chronic Kidney Disease and Type 2 Diabetes

This study is looking at a treatment called Physiologic Insulin Resensitization (PIR) for people with Chronic Kidney Disease (CKD) (stages 3b, 4, or 5) and Type 2 Diabetes Mellitus (T2DM). PIR is a treatment given by a doctor using an external pump to deliver insulin directly into your veins. The researchers want to see if PIR improves kidney function. They will measure things like your estimated Glomerular Filtration Rate (eGFR), Blood Urea Nitrogen/Creatinine Ratio (BUN/Cr), and Cystatin C at 12 and 24 weeks. You can join if you are 18 or older and have had CKD and T2DM for at least 6 months. The study aims to enroll 120 participants, but its current status is unclear.

Study design
This is an interventional study comparing Physiologic Insulin Resensitization (PIR) to standard care, with a planned enrollment of 120 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 24 weeks, with measurements taken at 12 and 24 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07187479

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

Recruiting
NAAges 18+InterventionalTreatment
Well Cell Global
~120 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Physiologic Insulin Resensitization (PIR)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Estimated Glomular Filtration Rate (eGFR)
Measured over 12 and 24 weeks
+3 more outcomes measured

Conditions

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

Explore related trials

Chronic Kidney DiseaseType 2 Diabetes Mellitus

NCT07187479

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arizona Kidney Disease and Hypertension Center

    Phoenix, Arizonastudy coordinator listed

    Recruiting

  • Innovative Diabetic Center

    Scottsdale, Arizonastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sungchun Lee, MD · PRINCIPAL_INVESTIGATOR · Arizona Kidney Disease and Hypertension Centers

Who to contact

Richard Marchase, PhD
[email protected]
205-612-4763
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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:
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

Exclusion

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:
Hb \<8 g/dL
WBC \<2,000/µL
Platelets \<50,000/µL
ALT, AST, or Alkaline Phosphatase \>5x ULN
ALT or AST \>2.5x ULN, and Total Bilirubin \>2x ULN
Serum albumin \<3 g/dL
Has - in the opinion of the Investigator - psychiatric, behavioral, cognitive and/or clinical dysfunction (whether or not related to known medical illness or drug / alcohol use) that would affect the subject's safety and/or compliance.
Is on active dialysis at time of screening

What this trial measures

  • Estimated Glomular Filtration Rate (eGFR)12 and 24 weeks

    Assess the eGFR of patients in the PIR group as compared to the SOC group

  • Blood Urea Nitrogen/Creatinine Ratio (BUN/Cr)12 and 24 weeks

    Assess the BUN/Cr of patients in the PIR group as compared to the SOC group

  • Cystatin C12 and 24 weeks

    Assess the Cystatin C of patients in the PIR group as compared to the SOC group

  • Urine albumin-creatinine ratio (ACR)12 and 24 weeks

    Assess the urine ACR of patients in the PIR group as compared to the SOC group