Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
Key facts
- Where
- Phoenix és Scottsdale, Egyesült ÁllamokSee the 2 sites
Where in Egyesült Államok
- Arizona Kidney Disease and Hypertension CenterPhoenix, Egyesült ÁllamokTaking people
- Innovative Diabetic CenterScottsdale, Egyesült ÁllamokTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Well Cell Global
- Trial code
- NCT07187479
- Record updated
- 2026. augusztus 4.
- Original 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).Read full original descriptionShow less
Randomized, Open Label Study to Examine the Outcomes of Physiologic Insulin Resensitization in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
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).
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:; 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: Has in the past two (2) years received treatment for a malignancy; Has in the past one (1) year used non-prescription opioids or psychoactive drugs; Has at screening a positive test for HIV (4th gen. screen), HBsAg, or HCV viral load; 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; 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; 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; Current pregnancy or intends to become pregnant during the study; Is nursing or is planning to nurse during the study; Is on active dialysis at time of screening.