Actively Recruiting
Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
Led by Well Cell Global · Updated on 2025-10-20
120
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
What this Trial 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).
CONDITIONS
Official 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 years 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 prior to screening
- On a stable, appropriate treatment regimen for managing any complications for at least 6 months
- Able to provide informed consent, understand and follow study procedures, and attend all required visits
- If female and of non-childbearing potential: age 50 or older and post-menopausal for at least 1 year or surgically sterile
- If female and of childbearing potential: negative pregnancy test at screening and agrees to use acceptable contraception from screening until 30 days after last study treatment
You will not qualify if you...
- Received treatment for malignancy in the past 2 years
- Currently pregnant or plans to become pregnant during the study
- Used non-prescription opioids or psychoactive drugs in the past year
- Experienced a hypoglycemic event requiring urgent care or specific treatments in the past 6 months unless approved
- Participated in a clinical study involving investigational drugs or glucose control methods in the past month
- Nursing or plans to nurse during the study
- Positive screening test for HIV, hepatitis B, or hepatitis C
- Abnormal lab results at screening including low hemoglobin, low white blood cells, low platelets, elevated liver enzymes, or low serum albumin
- Psychiatric, behavioral, cognitive, or clinical dysfunction that affects safety or compliance
- On active dialysis at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
S
Samantha Villaverde
CONTACT
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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