Chronic Kidney Disease (Stages 4 and 5), Kidney Disease, Type 2 Diabetes
Conditions
Keywords
chronic kidney disease, type 2 diabetes, diabetes, kidney disease
Brief summary
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
OTHERPhysiologic Insulin Resensitization (PIR)
PIR is a physician-directed treatment that uses an exterior infusion pump to deliver insulin intravenously.
Sponsors
Well Cell Global
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, Open Label Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Glomular Filtration Rate (eGFR) | 12 and 24 weeks | Assess the eGFR of patients in the PIR group as compared to the SOC group |
| Blood Urea Nitrogen/Creatinine Ratio (BUN/Cr) | 12 and 24 weeks | Assess the BUN/Cr of patients in the PIR group as compared to the SOC group |
| Cystatin C | 12 and 24 weeks | Assess the Cystatin C of patients in the PIR group as compared to the SOC group |
| Urine albumin-creatinine ratio (ACR) | 12 and 24 weeks | Assess the urine ACR of patients in the PIR group as compared to the SOC group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prescribed medication usage for control of symptoms | 12 and 24 weeks | Assess changes of medications in the PIR group as compared to the SOC group |
| Hemoglobin A1c (HbA1c) | 12 and 24 weeks | Assess the Hb1c of patients in the PIR group as compared to the SOC group |
| Fasting blood glucose | 12 and 24 weeks | Assess the fasting blood glucose of patients in the PIR group as compared to the SOC group |
| Fasting insulin level | 12 and 24 weeks | Assess the fasting insulin level of patients in the PIR group as compared to the SOC group |
| HOMA-IR | 12 and 24 weeks | Assess the HOMA-IR of patients in the PIR group as compared to the SOC group |
| Blood Pressure | 12 and 24 weeks | Assess the Blood Pressure of patients in the PIR group as compared to the SOC group |
| Lipid profile | 12 and 24 weeks | Assess the Lipid Profile of patients in the PIR group as compared to the SOC group |
| C peptide | 12 and 24 weeks | Assess the C peptide of patients in the PIR group as compared to the SOC group |
| EQ-5D-5L Quality of Life (EuroQol 5-Dimension 5-Level Questionnaire) | 12 and 24 weeks | Assess the Quality of Life of patients in the PIR group as compared to the SOC group. Lower health index scores reflect greater health deficits. |
Countries
United States
Contacts
CONTACTRichard Marchase, PhD
CONTACTSamantha Villaverde
PRINCIPAL_INVESTIGATORSungchun Lee, MD
Arizona Kidney Disease and Hypertension Centers
Outcome results
None listed