Actively Recruiting
Randomized, Open Label Study to Examine Outcomes of Physiologic Insulin Resensitization in Chronic Kidney Disease and Type 2 Diabetes Mellitus
Led by Well Cell Global · Updated on 2025-10-20
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates Physiologic Insulin Resensitization (PIR) treatment outcomes compared to standard care in patients with chronic kidney disease (CKD) stages 3b, 4, and 5 who also have Type 2 diabetes mellitus (T2DM). The study aims to assess how PIR influences kidney function and diabetes control in this patient group. The trial is randomized and open label, led by Well Cell Global, focusing on important kidney and diabetes markers over time. Participants are divided into two groups: one receives PIR, a physician-directed treatment using an external infusion pump to deliver insulin intravenously, while the other group receives standard care without additional intervention. The study collects data at 12 and 24 weeks to compare outcomes between these approaches. Participants will attend study visits to undergo assessments including kidney function tests like estimated glomerular filtration rate (eGFR), blood urea nitrogen/creatinine ratio, cystatin C, and urine albumin-creatinine ratio. Blood tests will measure glucose control, insulin levels, blood pressure, lipid profiles, and quality of life using questionnaires. The study monitors prescribed medication usage and overall health during the 24-week period to evaluate the impact of the treatments.
CONDITIONS
Brief Title
Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older (male or female)
- Documented diagnosis of chronic kidney disease stage 3b, 4, or 5 and Type 2 diabetes mellitus for at least 6 months before screening
- Stable treatment regimen for any complications for the past 6 months as judged by the investigator
- Ability to provide informed consent, understand study procedures, and attend all required visits
- Female participants must be either of non-childbearing potential or have a negative pregnancy test and agree to use birth control during the study
You will not qualify if you...
- Treatment for any malignancy within the past 2 years
- Current pregnancy or intention to become pregnant during the study
- Use of non-prescription opioids or psychoactive drugs within the past year
- Hypoglycemic event requiring urgent care within the past 6 months unless approved by Medical Monitor
- Participation in another clinical study involving investigational drugs or glucose control methods within the past month
- Nursing or planning to nurse during the study
- Positive screening test for HIV, hepatitis B surface antigen, or hepatitis C viral load
- Abnormal laboratory results including low hemoglobin, white blood cells, platelets, or elevated liver enzymes beyond specified limits
- Psychiatric, behavioral, cognitive, or clinical dysfunction affecting safety or compliance as assessed by investigator
- Active dialysis treatment at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive Physiologic Insulin Resensitization (PIR) treatment or standard of care to assess effects on chronic kidney disease and Type 2 diabetes mellitus.
Visits at 12 and 24 weeks for assessments
Trial Site Locations
Total: 1 location
1
Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, United States, 85027
Actively Recruiting
Research Team
R
Richard Marchase, PhD
S
Samantha Villaverde
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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