NCT07187479 · Well Cell Global
Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
What this study is about
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).
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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 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:
- 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
Where
- Phoenix, Arizona
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 20, 2025 · Source of record for eligibility and locations