Recruiting NCT07187479
Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physiologic Insulin Resensitization (PIR).
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease (Stages 4 and 5), Kidney Disease, Type 2 Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized, Open Label Study to Examine the Outcomes of Physiologic Insulin Resensitization in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
Overview
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).
Detailed description
The primary objective of this study is to assess the outcomes of Physiologic Insulin Resensitization (PIR) treatment compared to standard of care (SOC) on renal patients with a diagnosis of chronic kidney disease (CKD) (stages 3b, 4 and 5) and Type 2 diabetes mellitus (T2DM)
Interventions
- Other Physiologic Insulin Resensitization (PIR)
PIR is a physician-directed treatment that uses an exterior infusion pump to deliver insulin intravenously.
Primary outcome measures
- Estimated Glomular Filtration Rate (eGFR) [Time frame: 12 and 24 weeks]
- Blood Urea Nitrogen/Creatinine Ratio (BUN/Cr) [Time frame: 12 and 24 weeks]
- Cystatin C [Time frame: 12 and 24 weeks]
- Urine albumin-creatinine ratio (ACR) [Time frame: 12 and 24 weeks]
Secondary outcome measures (9)
- Prescribed medication usage for control of symptoms [Time frame: 12 and 24 weeks]
- Hemoglobin A1c (HbA1c) [Time frame: 12 and 24 weeks]
- Fasting blood glucose [Time frame: 12 and 24 weeks]
- Fasting insulin level [Time frame: 12 and 24 weeks]
- HOMA-IR [Time frame: 12 and 24 weeks]
- Blood Pressure [Time frame: 12 and 24 weeks]
- Lipid profile [Time frame: 12 and 24 weeks]
- C peptide [Time frame: 12 and 24 weeks]
- EQ-5D-5L Quality of Life (EuroQol 5-Dimension 5-Level Questionnaire) [Time frame: 12 and 24 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Arizona Kidney Disease and Hypertension Center — Phoenix
- Innovative Diabetic Center — Scottsdale
Identifiers
NCT: NCT07187479 · AZ-01