Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWell Cell Global
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Provide valid informed consent.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Physiologic Insulin Resensitization (PIR)
Other interventionPIR is a physician-directed treatment that uses an exterior infusion pump to deliver insulin intravenously.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Physiologic Insulin Resensitization (PIR) GroupExperimental treatment 1 intervention
Group B: Standard of Care (SOC) GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Estimated Glomular Filtration Rate (eGFR)
Assess the eGFR of patients in the PIR group as compared to the SOC group
Time frame
12 and 24 weeks2
Blood Urea Nitrogen/Creatinine Ratio (BUN/Cr)
Assess the BUN/Cr of patients in the PIR group as compared to the SOC group
Time frame
12 and 24 weeks3
Cystatin C
Assess the Cystatin C of patients in the PIR group as compared to the SOC group
Time frame
12 and 24 weeks4
Urine albumin-creatinine ratio (ACR)
Assess the urine ACR of patients in the PIR group as compared to the SOC group
Time frame
12 and 24 weeksSecondary outcomes
1
Prescribed medication usage for control of symptoms
Assess changes of medications in the PIR group as compared to the SOC group
Time frame
12 and 24 weeks2
Hemoglobin A1c (HbA1c)
Assess the Hb1c of patients in the PIR group as compared to the SOC group
Time frame
12 and 24 weeks3
Fasting blood glucose
Assess the fasting blood glucose of patients in the PIR group as compared to the SOC group
Time frame
12 and 24 weeks4
Fasting insulin level
Assess the fasting insulin level of patients in the PIR group as compared to the SOC group
Time frame
12 and 24 weeksSponsors and contacts
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Source ClinicalTrials.gov